K913945 is an FDA 510(k) clearance for the STABILET INFANT RADIANT WARMER MODEL 2000C. This device is classified as a Warmer, Infant Radiant (Class II - Special Controls, product code FMT).
Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on February 12, 1992, 161 days after receiving the submission on September 4, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K913945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1991 |
| Decision Date | February 12, 1992 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMT — Warmer, Infant Radiant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5130 |