The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Model Bx-3000 Oxygen Concentrator.
| Device ID | K822871 |
| 510k Number | K822871 |
| Device Name: | MODEL BX-3000 OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | HEALTHDYNE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-27 |
| Decision Date | 1982-10-22 |