The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Neocare Model 800 Infant Radiant Warmer.
| Device ID | K853926 |
| 510k Number | K853926 |
| Device Name: | NEOCARE MODEL 800 INFANT RADIANT WARMER |
| Classification | Warmer, Infant Radiant |
| Applicant | DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
| Contact | Edward T Griffith |
| Correspondent | Edward T Griffith DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-24 |
| Decision Date | 1986-02-26 |