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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K230052
Device Name Inogen Rove 6
Applicant
Inogen, Inc.
301 Coromar Dr.
Goleta,  CA  93117
Applicant Contact Sandra LeClair
Correspondent
Inogen, Inc.
301 Coromar Dr.
Goleta,  CA  93117
Correspondent Contact Sandra LeClair
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/06/2023
Decision Date 06/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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