| Device Classification Name |
Percussor, Powered-Electric
|
| 510(k) Number |
K913014 |
| Device Name |
EMS PERCUSSOR |
| Applicant |
| Engineered Medical Systems |
| 8529 Zionsville Rd. |
| P.O. Box 681514 |
|
Indianapolis,
IN
46268
|
|
| Applicant Contact |
JEFF QUINN |
| Correspondent |
| Engineered Medical Systems |
| 8529 Zionsville Rd. |
| P.O. Box 681514 |
|
Indianapolis,
IN
46268
|
|
| Correspondent Contact |
JEFF QUINN |
| Regulation Number | 868.5665 |
| Classification Product Code |
|
| Date Received | 07/08/1991 |
| Decision Date | 10/23/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|