MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT

Calculator, Predicted Values, Pulmonary Function

CARDINAL HEALTH GERMANY 234 GMBH

The following data is part of a premarket notification filed by Cardinal Health Germany 234 Gmbh with the FDA for Masterscope, Masterscope Ecg, Masterscope Ct.

Pre-market Notification Details

Device IDK082539
510k NumberK082539
Device Name:MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
ClassificationCalculator, Predicted Values, Pulmonary Function
Applicant CARDINAL HEALTH GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, Bavaria,  DE 97204
ContactThomas Rust
CorrespondentThomas Rust
CARDINAL HEALTH GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, Bavaria,  DE 97204
Product CodeBTY  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-02
Decision Date2008-12-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04057155000061 K082539 000
04057155000054 K082539 000
04057155000030 K082539 000
04057155000023 K082539 000
04057155000016 K082539 000
04057155000627 K082539 000
04057155000610 K082539 000

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