The following data is part of a premarket notification filed by Hill-rom Air-shields with the FDA for Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer.
| Device ID | K003335 |
| 510k Number | K003335 |
| Device Name: | RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER |
| Classification | Warmer, Infant Radiant |
| Applicant | HILL-ROM AIR-SHIELDS 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | Larry W Krasley |
| Correspondent | Larry W Krasley HILL-ROM AIR-SHIELDS 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-25 |
| Decision Date | 2000-11-17 |