ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000

Catheter, Electrode Recording, Or Probe, Electrode Recording

ZCV ,INC.

The following data is part of a premarket notification filed by Zcv ,inc. with the FDA for Zynergy Zolution Electrophysiology Catheter, Model Z50000.

Pre-market Notification Details

Device IDK991060
510k NumberK991060
Device Name:ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant ZCV ,INC. 298 FERNWOOD AVE. Edison,  NJ  08837
ContactPriscilla Whitehead Cox
CorrespondentPriscilla Whitehead Cox
ZCV ,INC. 298 FERNWOOD AVE. Edison,  NJ  08837
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-30
Decision Date2000-04-06
Summary:summary

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