K102182 is an FDA 510(k) clearance for the MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30. 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 May 9, 2011, 279 days after receiving the submission on August 3, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K102182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2010 |
| Decision Date | May 09, 2011 |
| Days to Decision | 279 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 |