SIMEOX 200 Airway Clearance Device— 510(k) K241091

Substantially Equivalent

Inogen, Inc.

FDA 510(k) clearance K241091 for SIMEOX 200 Airway Clearance Device, Substantially Equivalent on 2024-12-23. Applicant: Inogen, Inc.. Device class: 2.

Clearance details

Applicant
Inogen, Inc.
Product code
Code SDT
Device class
Class 2
Regulation
21 CFR 868.5665
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Goleta, CA, US
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