SeptAlign— 510(k) K233569

Substantially Equivalent

Spirair, Inc.

FDA 510(k) clearance K233569 for SeptAlign, Substantially Equivalent on 2024-03-22. 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
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