Cardiovascular Analzyer

Plethysmograph, Impedance

PhysioWave, Inc.

The following data is part of a premarket notification filed by Physiowave, Inc. with the FDA for Cardiovascular Analzyer.

Pre-market Notification Details

Device IDK172431
510k NumberK172431
Device Name:Cardiovascular Analzyer
ClassificationPlethysmograph, Impedance
Applicant PhysioWave, Inc. 1700 Wyatt Drive Suite 2 Santa Clara,  CA  95054
ContactLaurent Giovangrandi
CorrespondentDiana Degregorio
Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon,  CA  94583
Product CodeDSB  
Subsequent Product CodeDSK
Subsequent Product CodeDXN
CFR Regulation Number870.2770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-11
Decision Date2018-03-14
Summary:summary

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