Device Classification Name |
Analyzer, Pacemaker Generator Function
|
510(k) Number |
K760013 |
Device Name |
PACER SYSTEMS ANALYZER (CORDIS) |
Applicant |
CORDIS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CORDIS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.3630
|
Classification Product Code |
|
Date Received | 06/10/1976 |
Decision Date | 07/20/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|