510(k) K132489

INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) by Inogen, Inc. — Product Code CAW

K132489 is an FDA 510(k) premarket notification submitted by Inogen, Inc. for the device "INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)". The FDA issued a decision of Substantially Equivalent on June 20, 2014. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Inogen, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2014
Date Received
August 8, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type