| Device Classification Name |
System, Communication, Powered
|
| 510(k) Number |
K943035 |
| Device Name |
P.A.T. SYSTEM |
| Applicant |
| Mathews Assoc., Inc. |
| 645 Hickman Cir. |
|
Sanford,
FL
32771
|
|
| Applicant Contact |
DANIEL PERREAULT |
| Correspondent |
| Mathews Assoc., Inc. |
| 645 Hickman Cir. |
|
Sanford,
FL
32771
|
|
| Correspondent Contact |
DANIEL PERREAULT |
| Regulation Number | 890.3710 |
| Classification Product Code |
|
| Date Received | 06/27/1994 |
| Decision Date | 10/04/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|