TurbAlign— 510(k) K243655
Substantially EquivalentSpirair, Inc.
FDA 510(k) clearance K243655 for TurbAlign, Substantially Equivalent on 2025-07-11. Applicant: Spirair, Inc.. Device class: 1.
Clearance details
- Applicant
- Spirair, Inc.
- Product code
- Code LYA
- Device class
- Class 1
- Regulation
- 21 CFR 874.4780
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, Ca, US
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