VisuBreath
FDA 510(k) clearance K261633 · decided 2026-07-14
Clearance details
- K-number
- K261633
- Device name
- VisuBreath
- Applicant
- Affirm Medical Technologies II, LLC
- Decision
- Substantially Equivalent
- Date received
- 2026-05-18
- Decision date
- 2026-07-14
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- CCK
- Device class
- 2
- Regulation number
- 868.1400
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Piedmont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.