The following data is part of a premarket notification filed by Aeiomed Inc. with the FDA for Aura Cpap System.
| Device ID | K042945 |
| 510k Number | K042945 |
| Device Name: | AURA CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | AEIOMED INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring AEIOMED INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-25 |
| Decision Date | 2005-03-09 |
| Summary: | summary |