K832418 is an FDA 510(k) clearance for the OHIO TEMPERATURE SIMULATOR. This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Airco/Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 52 days after receiving the submission on July 22, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K832418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1983 |
| Decision Date | September 12, 1983 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMZ — Incubator, Neonatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5400 |