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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 K092890
Device Name ASTHMA MONITOR AM3
Applicant
CAREFUSION GERMANY 234 GMBH
LEIBNIZSTRASSE 7
HOECHBERG,  DE 97204
Applicant Contact ELMAR NIDERMEYER
Correspondent
CAREFUSION GERMANY 234 GMBH
LEIBNIZSTRASSE 7
HOECHBERG,  DE 97204
Correspondent Contact ELMAR NIDERMEYER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/21/2009
Decision Date 01/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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