K182862 is an FDA 510(k) clearance for the Servo Guard. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Maquet Critical Care AB (Solna, SE). The FDA issued a Cleared decision on October 21, 2019, 375 days after receiving the submission on October 11, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K182862 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2018 |
| Decision Date | October 21, 2019 |
| Days to Decision | 375 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | CAH - Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |