ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

ECHOCATH, INC.

The following data is part of a premarket notification filed by Echocath, Inc. with the FDA for Echomark(r) Electrophysiology Catheter.

Pre-market Notification Details

Device IDK933417
510k NumberK933417
Device Name:ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant ECHOCATH, INC. P.O. BOX 7224 Princeton,  NJ  08543 -7224
ContactFrank Debernardis
CorrespondentFrank Debernardis
ECHOCATH, INC. P.O. BOX 7224 Princeton,  NJ  08543 -7224
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-13
Decision Date1995-05-04

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