The following data is part of a premarket notification filed by Caire Inc. with the FDA for Caire Companion 5 Oxygen Concentrator.
| Device ID | K121167 |
| 510k Number | K121167 |
| Device Name: | CAIRE COMPANION 5 OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | CAIRE INC. 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 Ball Ground, GA 30107 |
| Contact | Ben Kadrlik |
| Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-04-17 |
| Decision Date | 2012-05-02 |