AIO Breathe
FDA 510(k) clearance K252525 · decided 2025-11-06
Clearance details
- K-number
- K252525
- Device name
- AIO Breathe
- Applicant
- Aiomega, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-08-11
- Decision date
- 2025-11-06
- Days to decision
- 87 days
- Clearance type
- Abbreviated
- Product code
- LRK
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tyler, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.