The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Oxygen Concentrator, Model Bx-5000.
| Device ID | K854374 |
| 510k Number | K854374 |
| Device Name: | OXYGEN CONCENTRATOR, MODEL BX-5000 |
| Classification | Generator, Oxygen, Portable |
| Applicant | HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Contact | Richard Sheffield |
| Correspondent | Richard Sheffield HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-30 |
| Decision Date | 1986-01-03 |