Device Classification Name |
bed, air fluidized
|
510(k) Number |
K942184 |
Device Name |
CLINITRON AT HOME AIR FLUIDED THERAPY |
Applicant |
SSI MEDICAL SERVICES, INC. |
4349 CORPORATE RD. |
CHARLESTON,
SC
29405
|
|
Applicant Contact |
THOMAS E MCFADDEN |
Correspondent |
SSI MEDICAL SERVICES, INC. |
4349 CORPORATE RD. |
CHARLESTON,
SC
29405
|
|
Correspondent Contact |
THOMAS E MCFADDEN |
Regulation Number | 890.5160
|
Classification Product Code |
|
Date Received | 05/04/1994 |
Decision Date | 02/07/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|