| Device Classification Name |
Blood Pressure Cuff
|
| 510(k) Number |
K910903 |
| Device Name |
INFLATE-A-CUFF #7014 |
| Applicant |
| Pa Medical Corp. |
| 1512 Nashville Highway |
| P.O. Box 1286 |
|
Columbia,
TN
38401
|
|
| Applicant Contact |
BAILEY VAUGHN |
| Correspondent |
| Pa Medical Corp. |
| 1512 Nashville Highway |
| P.O. Box 1286 |
|
Columbia,
TN
38401
|
|
| Correspondent Contact |
BAILEY VAUGHN |
| Regulation Number | 870.1120 |
| Classification Product Code |
|
| Date Received | 03/05/1991 |
| Decision Date | 05/08/1991 |
| 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
|
|
|