SENTRYSUITE PRODUCT LINE

Calculator, Predicted Values, Pulmonary Function

CAREFUSION GERMANY 234 GMBH

The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Sentrysuite Product Line.

Pre-market Notification Details

Device IDK122699
510k NumberK122699
Device Name:SENTRYSUITE PRODUCT LINE
ClassificationCalculator, Predicted Values, Pulmonary Function
Applicant CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg,  DE 97204
ContactElmar Niedermeyer
CorrespondentElmar Niedermeyer
CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg,  DE 97204
Product CodeBTY  
Subsequent Product CodeBZC
Subsequent Product CodeBZG
Subsequent Product CodeJEH
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-04
Decision Date2012-11-19
Summary:summary

NIH GUDID Devices

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