The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Babytherm 8004 Babytherm 8010.
| Device ID | K971198 |
| 510k Number | K971198 |
| Device Name: | BABYTHERM 8004 BABYTHERM 8010 |
| Classification | Warmer, Infant Radiant |
| Applicant | DRAGER, INC. 4101 PLEASENT VALLEY ROAD, SUITE 100 Chantilly, VA 22021 |
| Contact | Herald Kneuer |
| Correspondent | Herald Kneuer DRAGER, INC. 4101 PLEASENT VALLEY ROAD, SUITE 100 Chantilly, VA 22021 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-31 |
| Decision Date | 1997-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675419228 | K971198 | 000 |
| 04048675005063 | K971198 | 000 |