The following data is part of a premarket notification filed by Cardinal Health with the FDA for Airlife Misty Finity Large Volume Continuous Nebulizer.
| Device ID | K041418 |
| 510k Number | K041418 |
| Device Name: | AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Cardinal Health 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Lavenia Ford |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-05-27 |
| Decision Date | 2004-06-10 |
| Summary: | summary |