SeptAlign— 510(k) K251790

Substantially Equivalent

Spirair, Inc.

FDA 510(k) clearance K251790 for SeptAlign, Substantially Equivalent on 2026-01-16. Applicant: Spirair, Inc..

Clearance details

Applicant: Spirair, Inc.
Product code: Code NHB
Advisory panel: Ear, Nose, Throat
Date received: 2025-06-11
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, Ca, US

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