Device Classification Name |
table, obstetric (and accessories)
|
510(k) Number |
K915779 |
Device Name |
AFFINITY BED MODEL 3600 SERIES |
Applicant |
HILL-ROM, INC. |
1069 E. RT 46 |
BATESVILLE,
IN
47006
|
|
Applicant Contact |
JAMES G CARPENTER |
Correspondent |
HILL-ROM, INC. |
1069 E. RT 46 |
BATESVILLE,
IN
47006
|
|
Correspondent Contact |
JAMES G CARPENTER |
Regulation Number | 884.4900
|
Classification Product Code |
|
Date Received | 12/24/1991 |
Decision Date | 02/24/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|