| Device Classification Name |
Bed, Ac-Powered Adjustable Hospital
|
| 510(k) Number |
K951161 |
| Device Name |
MC ACCLAIM Q6000 BED |
| Applicant |
| Janco Consulting Services |
| 6839 Montevideo Rd. |
| Mississauga, Ontario |
|
L5n 1n7,
CA
L5N 1N7
|
|
| Applicant Contact |
JANET SHAW |
| Correspondent |
| Janco Consulting Services |
| 6839 Montevideo Rd. |
| Mississauga, Ontario |
|
L5n 1n7,
CA
L5N 1N7
|
|
| Correspondent Contact |
JANET SHAW |
| Regulation Number | 880.5100 |
| Classification Product Code |
|
| Date Received | 03/14/1995 |
| Decision Date | 05/09/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|