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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 K113813
Device Name SENTRYSUITE PRODUCT LINE
Applicant
Carefusion Germany 234 GmbH
Leibnizstrasse 7
Hoechberg,  DE 97204
Applicant Contact ELMAR NIEDERMEYER
Correspondent
Carefusion Germany 234 GmbH
Leibnizstrasse 7
Hoechberg,  DE 97204
Correspondent Contact ELMAR NIEDERMEYER
Regulation Number868.1890
Classification Product Code
BTY  
Subsequent Product Codes
BZC   BZG  
Date Received12/23/2011
Decision Date 05/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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