FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sotair Device
K Number: K212905
·
Decision Aug 18, 2022
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
1
Review Days
339
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Basic Information
- Device Name
- Sotair Device
- K Number
- K212905
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Safe Bvm Corporation
- Date Received
- September 13, 2021
- Decision Date
- August 18, 2022
- Product Code
- BTM
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
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