| Device Classification Name |
Table, Obstetrical, Ac-Powered (And Accessories)
|
| 510(k) Number |
K874610 |
| Device Name |
ADEL MODEL 2100 BIRTHING BED |
| Applicant |
| Adel Medical , Ltd. |
| 16700 SE 120th Ave. |
| P.O. Box 542 |
|
Clackamas,
OR
97015
|
|
| Applicant Contact |
MCCHORD |
| Correspondent |
| Adel Medical , Ltd. |
| 16700 SE 120th Ave. |
| P.O. Box 542 |
|
Clackamas,
OR
97015
|
|
| Correspondent Contact |
MCCHORD |
| Regulation Number | 884.4900 |
| Classification Product Code |
|
| Date Received | 11/09/1987 |
| Decision Date | 01/21/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|