| Device Classification Name |
Stretcher, Wheeled, Powered
|
| 510(k) Number |
K912175 |
| Device Name |
ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE |
| Applicant |
| Isotechnologies, Inc. |
| P.O. Box 1239 |
|
Hillsborough,
NC
27278
|
|
| Applicant Contact |
GILBERT R CHENERY |
| Correspondent |
| Isotechnologies, Inc. |
| P.O. Box 1239 |
|
Hillsborough,
NC
27278
|
|
| Correspondent Contact |
GILBERT R CHENERY |
| Regulation Number | 890.3690 |
| Classification Product Code |
|
| Date Received | 05/16/1991 |
| Decision Date | 06/07/1991 |
| 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
|
|
|