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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K051226
Device Name AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
Applicant
Cardinal Health
1430 WAUKEGAN ROAD, BLDG. KB
MCGAW PARK,  IL 
Applicant Contact SHARON NICHOLS
Correspondent
Cardinal Health
1430 WAUKEGAN ROAD, BLDG. KB
MCGAW PARK,  IL 
Correspondent Contact SHARON NICHOLS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/12/2005
Decision Date 11/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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