The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda 5000 Infant Warmer System.
| Device ID | K851449 |
| 510k Number | K851449 |
| Device Name: | OHMEDA 5000 INFANT WARMER SYSTEM |
| Classification | Warmer, Infant Radiant |
| Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | Raymond T Riddle |
| Correspondent | Raymond T Riddle OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-11 |
| Decision Date | 1985-06-07 |