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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K133925
Device Name VYNTUS/ 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 Number868.1880
Classification Product Code
BZC  
Date Received12/23/2013
Decision Date 08/22/2014
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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