The following data is part of a premarket notification filed by Cryogenic Assoc. with the FDA for Roommate-oxygen Concentrator.
| Device ID | K801104 |
| 510k Number | K801104 |
| Device Name: | ROOMMATE-OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | CRYOGENIC ASSOC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-09 |
| Decision Date | 1980-05-23 |