Soundable Health, Inc.

Address:50 California St,San Francisco,CA,94111,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Uroflowmeter (EXY) (1)

Premarket Exempt

Yes

Clear

proudP - 00860006184902 Catalog Number :

Device Description : proudP is a mobile application intended for measuring voided volume of urine and proudP is a mobile application intended for measuring voided volume of urine and urine flow rate using the sound recorded by microphone in mobile devices. This device can be used for assessment of voiding function.This device can be used at office or at home and required to be used in a quiet environment.This device targets patients over 18 years of age.

Device Class : 2

Duns Number: 116957774

Premarket Exempt : Yes

Product Code : EXY

Prescription Use : Yes

Device Count : 1

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