The following data is part of a premarket notification filed by Cardinal Health with the FDA for Airlife Nebulizer Cap.
Device ID | K072119 |
510k Number | K072119 |
Device Name: | AIRLIFE NEBULIZER CAP |
Classification | Nebulizer (direct Patient Interface) |
Applicant | Cardinal Health 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
Contact | Sharon Nichols |
Correspondent | Ned Levine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-08-01 |
Decision Date | 2007-08-10 |
Summary: | summary |