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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K090486
Device Name ASTHMA MONITOR MODEL, AM1
Applicant
Cardinal Health Germany 234 GmbH
Regulatory Affairs
1100 Bird Center Dr.
Palm Springs,  CA  92262
Applicant Contact THOMAS GUTIERREZ
Correspondent
Cardinal Health Germany 234 GmbH
Regulatory Affairs
1100 Bird Center Dr.
Palm Springs,  CA  92262
Correspondent Contact THOMAS GUTIERREZ
Regulation Number868.1840
Classification Product Code
BZG  
Date Received02/25/2009
Decision Date 05/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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