The following data is part of a premarket notification filed by Airon Corporation with the FDA for Macs Cpap System.
| Device ID | K080692 |
| 510k Number | K080692 |
| Device Name: | MACS CPAP SYSTEM |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | AIRON CORPORATION 129 W. HIBISCUS BLVD., SUITE S Melbourne, FL 32901 |
| Contact | Eric Gjerde |
| Correspondent | Eric Gjerde AIRON CORPORATION 129 W. HIBISCUS BLVD., SUITE S Melbourne, FL 32901 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-11 |
| Decision Date | 2008-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853678006665 | K080692 | 000 |
| 00853678006085 | K080692 | 000 |
| 00853678006047 | K080692 | 000 |
| 00853678006030 | K080692 | 000 |