SeptAlign (SPLN001)— 510(k) K260620
Substantially EquivalentSpirair, Inc.
FDA 510(k) clearance K260620 for SeptAlign (SPLN001), Substantially Equivalent on 2026-07-30. Applicant: Spirair, Inc.. Device class: 2.
Clearance details
- Applicant
- Spirair, Inc.
- Product code
- Code NHB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, Ca, US
Recent devices under product code NHB
view allMore clearances from Spirair, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.