1• W10/38Ultrasonic TableTop DopplerTraditional 510OK Submission Section 1

510(k) Summary of Safety and Effectiveness C 28 01

This summary of 510k safety and effectiveness is being submitted in according with 21 CFRpart 807.92

Submitter: Edan Instruments, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 10 1 9#,shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: 86-755-26882220Fax:86-755-26882223Contact person: Yue Qiuhong

Official correspondent:- William StemMultigon Jndustries,Inc..1 Odell PlazaYonkers, N.Y. 10701Phone: 914 376 5200 X27Fax: 914 376 6111

Date of Preparation: 2010-7-20

Proprietary Name: Ultrasonic TableTop Doppler (Models SD5, SD6)

Classification Name: 21 CFR 884.2660 Fetal ultrasonic monitor and accessories

21 CFR 884.2660 Ultrasound Blood Flow Monitor

Product code: MAA/JAF

Predicate Devices:

Prediate dvicesIMEXDPCT+ Sonotrax series pocket Ultrasonic TableTopPredicatedevices IEXDOP CT+Doppler Doppler

Manufaturer Imex Medical Edan Instruments,In EdnnsumtsManufaturer Systems, Inc EaIntuesnc Inc

_K# _____K942441 K080087 K092997

Device Description: Ultrasonic TableTop Doppler provides the following primary features:

* Basic parameters: FHR, blood flow* 240 seconds fetal heart sound record and playback* infrared communication(for 5D6 only)* Ni-MH battery for 20 hours continuous working of main unit* Li-ion battery for 2.5 hours continuous working of S06 probe

4/1

DEPARTMENT OF HEALTH & HUMAN SERVICES4 ~~~~~~~~~~~~~~~~~~~~~~~~Food and Drug- Administration10903 New Hampshire AvenueDocument Mail Center - W066-G609Silver Spring, MD 20993-0002

Ms. Yue QiuhongCertification EngineerEdan Instruments, Inc.3/F - B, Nanshan Medical Equipment Park O)CTI 28 201OShenzhen, Guangdong 5 18067CHINA

Re: K102138Trade/D~evice Name: Ultrasonic TableTop Doppler (models SD5 and SD6)Regulation Number: 21 CFR 884.2660Regulation Name: Fetal ultrasonic monitor and accessoriesRegulatory Class: IIProduct Code: MAA and JAFDated: September 29, 2010Received: October 4, 201 0

Dear Ms. Qiuhong:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and we have determined the device is substantially equivalent (for theindications for use stated in the enclosure) to legally marketed predicate devices marketed ininterstate commerce prior to May 28, 1976, the enactment date of the Medical DeviceAmendments, or to devices that have been reclassified in accordance with the provisions of theFederal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject tothe general controls provisions of the Act. The general controls provisions of the Act includerequirements for annual registration, listing of devices, good manufacturing practice, labeling,and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended foruse with the Ultrasonic TableTop Doppler (models SD5 and SD6), as described iii yourpremarket notification:

Transducer Model Number

5MHz CW Vascular Probe-model: 5D54MHz CW vascular probe-model 5D58MHz CW vascular probe-model 5D5

5MHz CW wireless vascular probe-model: 5D64MHz CW wireless vascular probe-model: SD68MHz CW wireless vascular probe-model 5D6'6

Page 2 - Ms. Qiuhong

If your device is classified (see above) into either class II (Special Controls) or class III (PMA),it may be subject to such additional contrbls. Existing major regulations affecting your devicecan be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDAmay publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarketnotification. The FDA finding of substantial equivalence of your device to a legally marketedpredicate device results in a classification for your device and thus permits your device toproceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasego to http://www.fda.gov/AboutFDA/CentersOffices/CDRI-ICDRFIOffiees/ucmI 15809.htm forthe Center for.Devices and Radiological Health's (CDRH-'s) Office of Compliance. Also, pleasenote the regulation entitled, "Misbranding by reference to premarket notification" (2 1 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation.(21CFR Part 803), please go tohttp://www.fda.govlMedicalDevices/SafetyfReportaProblem/default.htm for the CDRH's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Jana Delfino at(301) 796-6503.

Sincerely yours,

David G. Brown, Ph.D.Acting DirectorDivision of Radiological DevicesOffice of In Vitro Diagnostic DeviceEvaluation and Safety

Center for Devices and Radiological Health

Enclosure(s)

Ultrasonic TableTop Doppler

Traditional 510OK Submission Section

Indication for Usie

5 10(k) Number (if known): OCT 2 8 2010

Device Name: Ultrasonic TableTop Doppler (models SD5 and SD6)

The Ultrasonic TabieTop Doppler is intended to be used by health care professionals includingregistered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, byprescription from licensed physicians in hospitals, clinics and private offices.

The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from earlygestation tin-u delivery and as a general indication of fetal well being. They can also be used toverify fetal heart viability following patient trauma.

The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in

veins and arteries for assisting in the detection of peripheral vascular disease.

Prescription Use _________ And/Or Over the Counter Use _______

(21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)

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