The following data is part of a premarket notification filed by Draegerwerk Ag & Co. Kgaa with the FDA for Babyleo Tn500.
| Device ID | K162821 |
| 510k Number | K162821 |
| Device Name: | Babyleo TN500 |
| Classification | Incubator, Neonatal |
| Applicant | Draegerwerk AG & Co. KGaA Moislinger Allee 53-55 Luebeck, DE 23542 |
| Contact | Bettina Moebius |
| Correspondent | Bettina Moebius Draegerwerk AG & Co. KGaA Moislinger Allee 53-55 Luebeck, DE 23542 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-07 |
| Decision Date | 2017-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675436607 | K162821 | 000 |