| Device Classification Name |
Table, Obstetric (And Accessories)
|
| 510(k) Number |
K914544 |
| Device Name |
BD6000 THE OPTIMA & BD5000 BIRTHING BED |
| Applicant |
| Lic Care, Inc. |
| 521 W. Golf Rd. |
|
Arlington Heights,
IL
60005
|
|
| Applicant Contact |
GARTH E GREENBAUM |
| Correspondent |
| Lic Care, Inc. |
| 521 W. Golf Rd. |
|
Arlington Heights,
IL
60005
|
|
| Correspondent Contact |
GARTH E GREENBAUM |
| Regulation Number | 884.4900 |
| Classification Product Code |
|
| Date Received | 10/10/1991 |
| Decision Date | 11/24/1993 |
| 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
|
|
|