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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calculator, predicted values, pulmonary function
510(k) Number K122699
Device Name SENTRYSUITE PRODUCT LINE
Original Applicant
CAREFUSION GERMANY 234 GMBH
leibnizstrasse 7
hoechberg,  DE 97204
Original Contact elmar niedermeyer
Regulation Number868.1890
Classification Product Code
BTY  
Subsequent Product Codes
BZC   BZG   JEH  
Date Received09/04/2012
Decision Date 11/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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