The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohio Infant Warmer System.
| Device ID | K921766 |
| 510k Number | K921766 |
| Device Name: | OHIO INFANT WARMER SYSTEM |
| Classification | Warmer, Infant Radiant |
| Applicant | OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Contact | Alberto F Profumo |
| Correspondent | Alberto F Profumo OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-14 |
| Decision Date | 1993-04-23 |