K032818 is an FDA 510(k) clearance for the INOGEN ONE OXYGEN CONCENTRATOR. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Inogen, Inc. (Goleta, US). The FDA issued a Cleared decision on May 13, 2004, 246 days after receiving the submission on September 10, 2003.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K032818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2003 |
| Decision Date | May 13, 2004 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAW - Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |