The following data is part of a premarket notification filed by Inspiron Corp. with the FDA for Oxygen Concentrator.
| Device ID | K850346 |
| 510k Number | K850346 |
| Device Name: | OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | INSPIRON CORP. 8600 ARCHIBALD AVE. Rancho Cucamonga, CA 91730 |
| Contact | Thomas C Brewster |
| Correspondent | Thomas C Brewster INSPIRON CORP. 8600 ARCHIBALD AVE. Rancho Cucamonga, CA 91730 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-28 |
| Decision Date | 1985-02-04 |