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510(k) K241091

SIMEOX 200 Airway Clearance Device by Inogen, Inc. — Product Code SDT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 23, 2024
Date Received: April 22, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intra-Pulmonary Percussive Vibration (Ipv) Devices
Device Class: Class II
Regulation Number: 868.5665
Review Panel: AN
Submission Type

It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.