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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K011847
Device Name ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
Applicant
Zynergy Cardio Vasular (Zcv), Inc.
298 Fernwood Ave.
Edison,  NJ  08837
Applicant Contact JING ZHANG
Correspondent
Zynergy Cardio Vasular (Zcv), Inc.
298 Fernwood Ave.
Edison,  NJ  08837
Correspondent Contact JING ZHANG
Regulation Number870.1220
Classification Product Code
DRF  
Date Received06/13/2001
Decision Date 07/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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