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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K072119
Device Name AIRLIFE NEBULIZER CAP
Applicant
Cardinalhealth
1430 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact SHARON NICHOLS
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED LEVINE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/01/2007
Decision Date 08/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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