CARDIOMETRICS FLOWIRE & FLOMAP

Transducer, Ultrasonic, Diagnostic

CARDIOMETRICS, INC.

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

Pre-market Notification Details

Device IDK932536
510k NumberK932536
Device Name:CARDIOMETRICS FLOWIRE & FLOMAP
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View,  CA  94043
ContactSusan Osborne
CorrespondentSusan Osborne
CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View,  CA  94043
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-26
Decision Date1993-09-28

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