ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER

Transducer, Ultrasonic, Diagnostic

INTERSPEC, INC.

The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Ultrasound Imagaing System And Doppler Flowmeter.

Pre-market Notification Details

Device IDK920678
510k NumberK920678
Device Name:ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler,  PA  19002
ContactRichard Derman
CorrespondentRichard Derman
INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler,  PA  19002
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-14
Decision Date1992-04-02

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