| Device Classification Name |
System, Environmental Control, Powered
|
| 510(k) Number |
K921528 |
| Device Name |
HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM |
| Applicant |
| Hill-Rom, Inc. |
| Hwy. 46 |
|
Batesville,
TN
|
|
| Applicant Contact |
FORD WILDER |
| Correspondent |
| Hill-Rom, Inc. |
| Hwy. 46 |
|
Batesville,
TN
|
|
| Correspondent Contact |
FORD WILDER |
| Regulation Number | 890.3725 |
| Classification Product Code |
|
| Date Received | 04/02/1992 |
| Decision Date | 04/20/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|