Device Classification Name |
Bed, Flotation Therapy, Powered
|
510(k) Number |
K970636 |
Device Name |
TOTALCARE., MODULAR THERAPY SYSTEM (MTS) |
Applicant |
HILL-ROM, INC. |
1069 STATE ROUTE 46 EAST |
BATESVILLE,
IN
47006
|
|
Applicant Contact |
JAMES G CARPENTER |
Correspondent |
HILL-ROM, INC. |
1069 STATE ROUTE 46 EAST |
BATESVILLE,
IN
47006
|
|
Correspondent Contact |
JAMES G CARPENTER |
Regulation Number | 890.5170
|
Classification Product Code |
|
Date Received | 02/20/1997 |
Decision Date | 08/26/1997 |
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
|
|
|