The following data is part of a premarket notification filed by Monaghan Medical Corporation with the FDA for Aerovent Plus Chc.
| Device ID | K110273 |
| 510k Number | K110273 |
| Device Name: | AEROVENT PLUS CHC |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MONAGHAN MEDICAL CORPORATION 5 LATOUR AVENUE, SUITE 1600 Plattsburgh, NY 12901 |
| Contact | Cari J Reil |
| Correspondent | Cari J Reil MONAGHAN MEDICAL CORPORATION 5 LATOUR AVENUE, SUITE 1600 Plattsburgh, NY 12901 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-31 |
| Decision Date | 2011-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50604351858508 | K110273 | 000 |
| 50604351858102 | K110273 | 000 |