Sotair Device
FDA 510(k) clearance K212905 · decided 2022-08-18
Clearance details
- K-number
- K212905
- Device name
- Sotair Device
- Applicant
- Safe Bvm Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-09-13
- Decision date
- 2022-08-18
- Days to decision
- 339 days
- Clearance type
- Traditional
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Chesterfield, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.