K970074 is an FDA 510(k) clearance for the STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D). 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 April 3, 1997, 85 days after receiving the submission on January 8, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K970074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 1997 |
| Decision Date | April 03, 1997 |
| Days to Decision | 85 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 |