The following data is part of a premarket notification filed by Inogen, Inc. with the FDA for Inogen At Home Oxygen Concentrator (aka Inogen At Home).
| Device ID | K132489 |
| 510k Number | K132489 |
| Device Name: | INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) |
| Classification | Generator, Oxygen, Portable |
| Applicant | INOGEN, INC. 326 BOLLAY DRIVE Goleta, CA 93117 |
| Contact | Mara Korsunsky |
| Correspondent | Mara Korsunsky INOGEN, INC. 326 BOLLAY DRIVE Goleta, CA 93117 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-08 |
| Decision Date | 2014-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817131020148 | K132489 | 000 |
| 00817131020131 | K132489 | 000 |