The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for H-3000 Oxygen Concentrator.
| Device ID | K890150 |
| 510k Number | K890150 |
| Device Name: | H-3000 OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Contact | Tim Cowart |
| Correspondent | Tim Cowart 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 | 1989-01-13 |
| Decision Date | 1989-01-31 |