Device Classification Name |
bed, flotation therapy, powered
|
510(k) Number |
K122473 |
Device Name |
TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 |
Applicant |
HILL-ROM |
1069 STATE ROUTE 46 EAST |
BATESVILLE,
IN
47006
|
|
Applicant Contact |
ANN WATERHOUSE |
Correspondent |
HILL-ROM |
1069 STATE ROUTE 46 EAST |
BATESVILLE,
IN
47006
|
|
Correspondent Contact |
ANN WATERHOUSE |
Regulation Number | 890.5170
|
Classification Product Code |
|
Date Received | 08/14/2012 |
Decision Date | 06/03/2013 |
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
|
|
|