The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Drager Infant Radiant Warmern Rh600.
| Device ID | K953489 |
| 510k Number | K953489 |
| Device Name: | DRAGER INFANT RADIANT WARMERN RH600 |
| Classification | Warmer, Infant Radiant |
| 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 | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-25 |
| Decision Date | 1996-02-09 |