Sotair Device— 510(k) K212905
Substantially EquivalentSafe Bvm Corporation
FDA 510(k) clearance K212905 for Sotair Device, Substantially Equivalent on 2022-08-18. Applicant: Safe Bvm Corporation.
Clearance details
- Applicant
- Safe Bvm Corporation
- Product code
- Code BTM
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chesterfield, MO, US
Adverse events under product code BTM
product code BTM- Death
- 19
- Other
- 2
- Total
- 21
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.