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FDA 510(k)

SONOTRAX SERIES ULTRASONIC POCKET DOPPLER

K-Number: K101960 · 2010-08-10

ApplicantEdan Instruments, Inc.
Decision Date2010-08-10
Product CodeHEP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SONOTRAX SERIES ULTRASONIC POCKET DOPPLER is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2010-08-10 under 510(k) number K101960. The device is classified under product code HEP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOTRAX SERIES ULTRASONIC POCKET DOPPLER?

SONOTRAX SERIES ULTRASONIC POCKET DOPPLER is a medical device that received FDA 510(k) clearance on 2010-08-10. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K101960.

When did SONOTRAX SERIES ULTRASONIC POCKET DOPPLER receive FDA 510(k) clearance?

SONOTRAX SERIES ULTRASONIC POCKET DOPPLER received FDA 510(k) clearance on 2010-08-10, under 510(k) number K101960.

Who is the listed applicant for SONOTRAX SERIES ULTRASONIC POCKET DOPPLER?

The FDA 510(k) record lists Edan Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOTRAX SERIES ULTRASONIC POCKET DOPPLER?

The FDA product code for SONOTRAX SERIES ULTRASONIC POCKET DOPPLER is HEP.

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Related Devices (Code: HEP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K023082BABYCAREBionet Company, Ltd.K920353ULTRACELL INSTRUMENT WIPEUltracell Medical Technologies, Inc.K910462POCKET DOP 3Imex Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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