K173516 is an FDA 510(k) clearance for the NuBorne Infant Warmer. This device is classified as a Warmer, Infant Radiant (Class II - Special Controls, product code FMT).
Submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on August 17, 2018, 276 days after receiving the submission on November 14, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K173516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2017 |
| Decision Date | August 17, 2018 |
| Days to Decision | 276 days |
| Submission Type | Abbreviated |
| 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 |