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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30889483571327 | K041418 | 000 |
30889483571242 | K041418 | 000 |
30889483571259 | K041418 | 000 |
30889483571273 | K041418 | 000 |
30889483571280 | K041418 | 000 |
30889483571297 | K041418 | 000 |
30889483569171 | K041418 | 000 |
30889483571266 | K041418 | 000 |
30889483571303 | K041418 | 000 |
30889483571310 | K041418 | 000 |
30889483569188 | K041418 | 000 |