The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Drager Incubator 8000 Ic.
| Device ID | K954204 |
| 510k Number | K954204 |
| Device Name: | DRAGER INCUBATOR 8000 IC |
| Classification | Incubator, Neonatal |
| Applicant | DRAGER, INC. 4101-100 PLEASANT VALLEY RD. Chantilly, VA 22021 |
| Contact | Harald Kneuer |
| Correspondent | Harald Kneuer DRAGER, INC. 4101-100 PLEASANT VALLEY RD. Chantilly, VA 22021 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1997-04-25 |