FLOWIRE AND FLOMAP

Flowmeter, Blood, Cardiovascular

CARDIOMETRICS, INC.

The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Flowire And Flomap.

Pre-market Notification Details

Device IDK905411
510k NumberK905411
Device Name:FLOWIRE AND FLOMAP
ClassificationFlowmeter, Blood, Cardiovascular
Applicant CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View,  CA  94043
ContactMichael J Billig
CorrespondentMichael J Billig
CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View,  CA  94043
Product CodeDPW  
CFR Regulation Number870.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-03
Decision Date1991-03-29

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