The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Stabilet Infant Radiant Warmer Model 2000c.
| Device ID | K913945 |
| 510k Number | K913945 |
| Device Name: | STABILET INFANT RADIANT WARMER MODEL 2000C |
| Classification | Warmer, Infant Radiant |
| Applicant | HILL-ROM, INC. HIGHWAY 46 Batesville, TN |
| Contact | Ford Wilder |
| Correspondent | Ford Wilder HILL-ROM, INC. HIGHWAY 46 Batesville, TN |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-04 |
| Decision Date | 1992-02-12 |