Sentry WEB SmartInterp

Computer, Diagnostic, Programmable

CareFusion Germany 234 GmbH

The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Sentry Web Smartinterp.

Pre-market Notification Details

Device IDK153654
510k NumberK153654
Device Name:Sentry WEB SmartInterp
ClassificationComputer, Diagnostic, Programmable
Applicant CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg,  DE 97204
ContactElmar Niedermeyer
CorrespondentElmar Niedermeyer
CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg,  DE 97204
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-21
Decision Date2016-09-16
Summary:summary

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