| Device Classification Name |
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
|
| 510(k) Number |
K872368 |
| Device Name |
MODIFIED VERSA STIM ELECTRODE LINE |
| Applicant |
| Conmedcorp |
| 310 Broad St. |
|
Utica,
NY
13501
|
|
| Applicant Contact |
WILLIAM W ABRAHAM |
| Correspondent |
| Conmedcorp |
| 310 Broad St. |
|
Utica,
NY
13501
|
|
| Correspondent Contact |
WILLIAM W ABRAHAM |
| Regulation Number | 870.5550 |
| Classification Product Code |
|
| Date Received | 06/18/1987 |
| Decision Date | 09/18/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|