The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for H-500 Alliance Oxygen Concentrator.
| Device ID | K942357 |
| 510k Number | K942357 |
| Device Name: | H-500 ALLIANCE OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | HEALTHDYNE, INC. 1255 KENNESTONE CIRCLE Marietta, GA 30066 |
| Contact | Timothy Y Cowart |
| Correspondent | Timothy Y Cowart HEALTHDYNE, INC. 1255 KENNESTONE CIRCLE Marietta, GA 30066 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-17 |
| Decision Date | 1994-05-27 |