The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Globe-trotter Gt5400.
| Device ID | K141565 |
| 510k Number | K141565 |
| Device Name: | GLOBE-TROTTER GT5400 |
| Classification | Incubator, Neonatal Transport |
| Applicant | Draeger Medical Systems, Inc. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | Gale Winarsky |
| Correspondent | Gale Winarsky Draeger Medical Systems, Inc. 3135 QUARRY RD. Telford, PA 18969 |
| Product Code | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-12 |
| Decision Date | 2014-09-10 |
| Summary: | summary |