The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ohio 3300 Infant Warmer System.
| Device ID | K840858 |
| 510k Number | K840858 |
| Device Name: | OHIO 3300 INFANT WARMER SYSTEM |
| Classification | Warmer, Infant Radiant |
| Applicant | OHIO MEDICAL PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-03-23 |