FDA 510(k) Application Details - K241091

Device Classification Name	More FDA Info for this Device
510(K) Number	K241091
Device Name	SIMEOX 200 Airway Clearance Device
Applicant	Inogen, Inc. 859 Ward Drive Suite 200 Goleta, CA 93111 US Other 510(k) Applications for this Company
Contact	Carole Harris Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SDT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2024
Decision Date	12/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review