Device Classification Name |
bed, air fluidized
|
510(k) Number |
K964223 |
Device Name |
CLINITRON RITE-HITE |
Applicant |
HILL-ROM, INC. |
4349 CORPORATE RD. |
CHARLESTON,
SC
29405
|
|
Applicant Contact |
EDWIN HILLS |
Correspondent |
HILL-ROM, INC. |
4349 CORPORATE RD. |
CHARLESTON,
SC
29405
|
|
Correspondent Contact |
EDWIN HILLS |
Regulation Number | 890.5160
|
Classification Product Code |
|
Date Received | 10/23/1996 |
Decision Date | 05/28/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|