Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System— 510(k) K191027
Substantially EquivalentMaquet Critical Care AB
FDA 510(k) clearance K191027 for Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System, Substantially Equivalent on 2020-03-18. Applicant: Maquet Critical Care AB.
Clearance details
- Applicant
- Maquet Critical Care AB
- Product code
- Code BSZ
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Solna, SE
Adverse events under product code BSZ
product code BSZ- Death
- 23
- Injury
- 298
- Malfunction
- 32,987
- Total
- 33,308
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.