K160665 is an FDA 510(k) clearance for the FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40. This device is classified as a Gas-machine, Anesthesia (Class II - Special Controls, product code BSZ).
Submitted by Maquet Critical Care AB (Solna, SE). The FDA issued a Cleared decision on March 29, 2017, 385 days after receiving the submission on March 9, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K160665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2016 |
| Decision Date | March 29, 2017 |
| Days to Decision | 385 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 |