The following data is part of a premarket notification filed by Dragerwerk Ag & Co. Kgaa with the FDA for Babyleo Tn500.
| Device ID | K182859 |
| 510k Number | K182859 |
| Device Name: | Babyleo TN500 |
| Classification | Incubator, Neonatal |
| Applicant | Dragerwerk AG & Co. KGaA Moislinger Allee 53-55 Lubeck, DE 23542 |
| Contact | Dr. Bettina Mobius |
| Correspondent | Gale Winarsky Draeger Medical Sytems, Inc. 3135 Quarry Road Telford, PA 18969 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-11 |
| Decision Date | 2019-02-22 |
| Summary: | summary |