Freespira Breathing System— 510(k) K233337
Substantially EquivalentFreespira, Inc.
FDA 510(k) clearance K233337 for Freespira Breathing System, Substantially Equivalent on 2025-04-24. Applicant: Freespira, Inc.. Device class: 2.
Clearance details
- Applicant
- Freespira, Inc.
- Product code
- Code SEN
- Device class
- Class 2
- Regulation
- 21 CFR 882.5050
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kirkland, WA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.