Device Classification Name |
warmer, infant radiant
|
510(k) Number |
K913945 |
Device Name |
STABILET INFANT RADIANT WARMER MODEL 2000C |
Applicant |
HILL-ROM, INC. |
HIGHWAY 46 |
BATESVILLE,
TN
|
|
Applicant Contact |
FORD WILDER |
Correspondent |
HILL-ROM, INC. |
HIGHWAY 46 |
BATESVILLE,
TN
|
|
Correspondent Contact |
FORD WILDER |
Regulation Number | 880.5130
|
Classification Product Code |
|
Date Received | 09/04/1991 |
Decision Date | 02/12/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|