CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND

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 Doppler Ultrasound.

Pre-market Notification Details

Device IDK912776
510k NumberK912776
Device Name:CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View,  CA  94043
ContactMichael Billig
CorrespondentMichael Billig
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 Received1991-06-24
Decision Date1992-01-09

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