The following data is part of a premarket notification filed by Carefusion with the FDA for Airlife Misty Finity Nebulizer.
| Device ID | K153748 |
| 510k Number | K153748 |
| Device Name: | AirLife Misty Finity Nebulizer |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | CareFusion 75 N Fairway Drive Vernon Hills, IL 60047 |
| Contact | Erika Fernandez |
| Correspondent | Colleen O'keeffe Vyaire Medical 26125 Riverwoods Blvd Mettawa, IL 60045 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-29 |
| Decision Date | 2017-05-17 |
| Summary: | summary |