K141565 is an FDA 510(k) clearance for the GLOBE-TROTTER GT5400. This device is classified as a Incubator, Neonatal Transport (Class II - Special Controls, product code FPL).
Submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on September 10, 2014, 90 days after receiving the submission on June 12, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5410.
| 510(k) Number | K141565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2014 |
| Decision Date | September 10, 2014 |
| Days to Decision | 90 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 |