K133958 is an FDA 510(k) clearance for the FLOW-I ANESTHESIA SYSTEM C20, C30 & 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 March 20, 2014, 86 days after receiving the submission on December 24, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K133958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2013 |
| Decision Date | March 20, 2014 |
| Days to Decision | 86 days |
| Submission Type | Abbreviated |
| 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 |