Freespira Breathing System
FDA 510(k) clearance K233337 · decided 2025-04-24
Clearance details
- K-number
- K233337
- Device name
- Freespira Breathing System
- Applicant
- Freespira, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-29
- Decision date
- 2025-04-24
- Days to decision
- 573 days
- Clearance type
- Traditional
- Product code
- SEN
- Device class
- 2
- Regulation number
- 882.5050
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kirkland, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.