Servo Guard— 510(k) K182862
Substantially EquivalentMaquet Critical Care AB
FDA 510(k) clearance K182862 for Servo Guard, Substantially Equivalent on 2019-10-21. Applicant: Maquet Critical Care AB.
Clearance details
- Applicant
- Maquet Critical Care AB
- Product code
- Code CAH
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Solna, SE
Adverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.