K120642 is an FDA 510(k) clearance for the RESUSCITAIRE WITH AUTOBREATH. This device is classified as a Warmer, Infant Radiant (Class II - Special Controls, product code FMT).
Submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on November 2, 2012, 245 days after receiving the submission on March 2, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K120642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2012 |
| Decision Date | November 02, 2012 |
| Days to Decision | 245 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 |