MICRO I

Spirometer, Diagnostic

CAREFUSION GERMANY 234 GMBH

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

Pre-market Notification Details

Device IDK113096
510k NumberK113096
Device Name:MICRO I
ClassificationSpirometer, Diagnostic
Applicant CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, Bavaria,  DE 97204
ContactElmar Niedermeyer
CorrespondentElmar Niedermeyer
CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, Bavaria,  DE 97204
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-19
Decision Date2012-04-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
54250892905582 K113096 000
54250892901355 K113096 000
14250892904433 K113096 000
14250892904099 K113096 000
14250892906543 K113096 000

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