The following data is part of a premarket notification filed by O2 Concepts Llc with the FDA for O2 Concepts Oxlife Independence Model 301-0001.
| Device ID | K182454 |
| 510k Number | K182454 |
| Device Name: | O2 Concepts Oxlife Independence Model 301-0001 |
| Classification | Generator, Oxygen, Portable |
| Applicant | O2 Concepts LLC 199 Park Road Extension Middlebury, CT 06762 |
| Contact | Kathryn G. Forgione |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-09-07 |
| Decision Date | 2018-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869694000105 | K182454 | 000 |
| 00869694000129 | K182454 | 000 |
| 00869694000136 | K182454 | 000 |