Submission Details
| 510(k) Number | K182862 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Servo Guard
Oct 2019
Decision
375d
Days
Class 2
Risk
About This 510(k) Submission
K182862 is an FDA 510(k) clearance for the Servo Guard, 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 review panel. Regulated under 21 CFR 868.5260.
Device Classification
| Product Code | CAH — Filter, Bacterial, Breathing-circuit |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5260 |
Manufacturer
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