K220742 is an FDA 510(k) clearance for the NxtGen Infant Transport Incubator. This device is classified as a Incubator, Neonatal Transport (Class II - Special Controls, product code FPL).
Submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on July 15, 2022, 123 days after receiving the submission on March 14, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5410.
| 510(k) Number | K220742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2022 |
| Decision Date | July 15, 2022 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPL - Incubator, Neonatal Transport |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5410 |