K840858 is an FDA 510(k) clearance for the OHIO 3300 INFANT WARMER SYSTEM. This device is classified as a Warmer, Infant Radiant (Class II - Special Controls, product code FMT).
Submitted by Ohio Medical Products (Walker, US). The FDA issued a Cleared decision on March 23, 1984, 28 days after receiving the submission on February 24, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K840858 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 1984 |
| Decision Date | March 23, 1984 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMT — Warmer, Infant Radiant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5130 |