SONOTRAX SERIES ULTRASONIC POCKET DOPPLER— 510(k) K101960

Substantially Equivalent

Edan Instruments, Inc.

FDA 510(k) clearance K101960 for SONOTRAX SERIES ULTRASONIC POCKET DOPPLER, Substantially Equivalent on 2010-08-10. Applicant: Edan Instruments, Inc..

Clearance details

Applicant: Edan Instruments, Inc.
Product code: Code HEP
Advisory panel: Obstetrics/Gynecology
Date received: 2010-07-12
Decision date: 2010-08-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, CN

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