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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K142959
Device Name Vyntus Walk
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 Number870.2700
Classification Product Code
DQA  
Date Received10/14/2014
Decision Date 03/20/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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