K840356 is an FDA 510(k) clearance for the OHIO UNITROL II ANESTHESIA GAS MACHINE. This device is classified as a Gas-machine, Anesthesia (Class II - Special Controls, product code BSZ).
Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on April 20, 1984, 85 days after receiving the submission on January 26, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K840356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1984 |
| Decision Date | April 20, 1984 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BSZ — Gas-machine, Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5160 |