ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1

Transducer, Ultrasonic

ECHOCATH, INC.

The following data is part of a premarket notification filed by Echocath, Inc. with the FDA for Echoflow Portable Doppler Blood Flow Measurement System; Model Pef-1.

Pre-market Notification Details

Device IDK010482
510k NumberK010482
Device Name:ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1
ClassificationTransducer, Ultrasonic
Applicant ECHOCATH, INC. 4326 U.S. ROUTE #1 Monmouth Junction,  NJ  08852
ContactDavid Lyons
CorrespondentDavid Lyons
ECHOCATH, INC. 4326 U.S. ROUTE #1 Monmouth Junction,  NJ  08852
Product CodeJOP  
CFR Regulation Number870.2880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-20
Decision Date2001-03-20

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