| Device Classification Name |
Bed, Air Fluidized
|
| 510(k) Number |
K884835 |
| Device Name |
TASSI MK2 |
| Applicant |
| Therapy Air Support Systems, Inc. |
| 13912 Ponderosa, Unit-H |
|
Santa Ana,
CA
92705
|
|
| Applicant Contact |
BILL ROSS |
| Correspondent |
| Therapy Air Support Systems, Inc. |
| 13912 Ponderosa, Unit-H |
|
Santa Ana,
CA
92705
|
|
| Correspondent Contact |
BILL ROSS |
| Regulation Number | 890.5160 |
| Classification Product Code |
|
| Date Received | 11/18/1988 |
| Decision Date | 12/07/1988 |
| 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
|
|
|