Healthdyne, Inc. · Class II · Cleared May 27, 1994
| K-number | K942357 |
| Device name | H-500 ALLIANCE OXYGEN CONCENTRATOR |
| Applicant | Healthdyne, Inc. |
| Product code | CAW |
| Device class | Class II |
| Decision date | May 27, 1994 |
| Decision | Substantially Equivalent |
| Regulation | 868.5440 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov