The following data is part of a premarket notification filed by Inogen, Inc. with the FDA for Inogen One Oxygen Concentrator.
| Device ID | K032818 |
| 510k Number | K032818 |
| Device Name: | INOGEN ONE OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | INOGEN, INC. 120 CREMONA DRIVE SUITE B Goleta, CA 93117 |
| Contact | John Wells |
| Correspondent | John Wells INOGEN, INC. 120 CREMONA DRIVE SUITE B 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 | 2003-09-10 |
| Decision Date | 2004-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817131020179 | K032818 | 000 |
| 00817131020162 | K032818 | 000 |
| 00817131020018 | K032818 | 000 |
| 00817131020025 | K032818 | 000 |
| 00817131020032 | K032818 | 000 |
| 00817131020049 | K032818 | 000 |
| 00817131020056 | K032818 | 000 |
| 00817131020063 | K032818 | 000 |
| 00817131020070 | K032818 | 000 |
| 00817131020087 | K032818 | 000 |
| 00817131020094 | K032818 | 000 |
| 00817131020100 | K032818 | 000 |
| 00817131020117 | K032818 | 000 |
| 00817131020124 | K032818 | 000 |
| 00817131020186 | K032818 | 000 |