K112114 is an FDA 510(k) clearance for the MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40. This device is classified as a Gas-machine, Anesthesia (Class II - Special Controls, product code BSZ).
Submitted by Maquet Critical Care AB (Wayne, US). The FDA issued a Cleared decision on January 13, 2012, 172 days after receiving the submission on July 25, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K112114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2011 |
| Decision Date | January 13, 2012 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSZ - Gas-machine, Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5160 |