The following data is part of a premarket notification filed by Proto-med, Inc. with the FDA for The Generic Oxygen Concentrator.
| Device ID | K844852 |
| 510k Number | K844852 |
| Device Name: | THE GENERIC OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | PROTO-MED, INC. 5360 MANHATTAN CIRCLE Boulder, CO 80303 |
| Contact | John A Sichel |
| Correspondent | John A Sichel PROTO-MED, INC. 5360 MANHATTAN CIRCLE Boulder, CO 80303 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-13 |
| Decision Date | 1984-12-27 |