K942904 is an FDA 510(k) clearance for the STABILET. 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 September 16, 1994, 87 days after receiving the submission on June 21, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K942904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1994 |
| Decision Date | September 16, 1994 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMT — Warmer, Infant Radiant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5130 |