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 Number | 870.1220
|
Classification Product Code |
|
Date Received | 06/13/2001 |
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
|
|
|