The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda - Ohio(r) 3500 Infant Warmer System.
| Device ID | K884160 |
| 510k Number | K884160 |
| Device Name: | OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM |
| Classification | Warmer, Infant Radiant |
| Applicant | OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Contact | F Profumo |
| Correspondent | 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 | 1988-10-04 |
| Decision Date | 1988-11-21 |