K191027 is an FDA 510(k) clearance for the Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System. 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 18, 2020, 335 days after receiving the submission on April 18, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K191027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2019 |
| Decision Date | March 18, 2020 |
| Days to Decision | 335 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 |