K121625 is an FDA 510(k) clearance for the LULLABY TM WARMER. This device is classified as a Warmer, Infant Radiant (Class II - Special Controls, product code FMT).
Submitted by Wipro GE Healthcare Private, Ltd. (Laurel, US). The FDA issued a Cleared decision on September 14, 2012, 105 days after receiving the submission on June 1, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K121625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2012 |
| Decision Date | September 14, 2012 |
| Days to Decision | 105 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 |