Sonotrax Series Ultrasonic Pocket Doppler

FDA 510(k) K101960 · Edan Instruments, Inc.

Substantially Equivalent

510(k) numberK101960

Submission

Device name
Sonotrax Series Ultrasonic Pocket Doppler
Applicant
Edan Instruments, Inc.
Shenzhen, CN
Received
July 12, 2010
Decision date
August 10, 2010
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HEP – Monitor, Blood-Flow, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2660
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HEP

510(k)DeviceApplicantDecision
K023082BabycareHEP · Abbreviated Bionet Company, Ltd.03/03/2003SE
K920353Ultracell Instrument WipeHEP · Traditional Ultracell Medical Technologies, Inc.09/15/1992SE
K910462Pocket Dop 3HEP · Traditional Imex Medical Systems, Inc.06/24/1991SE

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Questions and answers

When was Sonotrax Series Ultrasonic Pocket Doppler cleared by the FDA?

Sonotrax Series Ultrasonic Pocket Doppler (K101960) received a 510(k) decision of Substantially Equivalent on August 10, 2010, 29 days after the submission was received.

What is the product code of K101960?

The FDA product code is HEP – Monitor, Blood-Flow, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 884.2660.