K971366 is an FDA 510(k) clearance for the INCUWARMER. 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 January 5, 1998, 266 days after receiving the submission on April 14, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K971366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1997 |
| Decision Date | January 05, 1998 |
| Days to Decision | 266 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 |