| Device Classification Name |
Bed, Ac-Powered Adjustable Hospital
|
| 510(k) Number |
K971546 |
| Device Name |
SOMA 900 TRANSPORT BED |
| Applicant |
| Nova Technologies, Inc. |
| 545 Middle St. |
|
Bristol,
CT
06010
|
|
| Applicant Contact |
SAMUEL N PAUL |
| Correspondent |
| Nova Technologies, Inc. |
| 545 Middle St. |
|
Bristol,
CT
06010
|
|
| Correspondent Contact |
SAMUEL N PAUL |
| Regulation Number | 880.5100 |
| Classification Product Code |
|
| Date Received | 04/28/1997 |
| Decision Date | 07/10/1997 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|