| K-number | K080692 |
| Device name | MACS CPAP SYSTEM |
| Applicant | Airon Corporation |
| Product code | BTL |
| Device class | Class II |
| Decision date | Jun 20, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 868.5925 |
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