The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Stabilet.
| Device ID | K942904 |
| 510k Number | K942904 |
| Device Name: | STABILET |
| Classification | Warmer, Infant Radiant |
| Applicant | HILL-ROM, INC. 1069 STATE ROUTE 46 EAST Batesville, IN 47006 |
| Contact | James G Carpenter |
| Correspondent | James G Carpenter HILL-ROM, INC. 1069 STATE ROUTE 46 EAST Batesville, IN 47006 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-21 |
| Decision Date | 1994-09-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STABILET 74539342 1984990 Dead/Cancelled |
Hill-Rom Company, Inc. 1994-06-10 |
![]() STABILET 73501554 1391502 Dead/Cancelled |
BROEN ARMATUR A/S 1984-09-28 |