CARDIOVIT AT-102 G2

Electrocardiograph

Schiller AG

The following data is part of a premarket notification filed by Schiller Ag with the FDA for Cardiovit At-102 G2.

Pre-market Notification Details

Device IDK183425
510k NumberK183425
Device Name:CARDIOVIT AT-102 G2
ClassificationElectrocardiograph
Applicant Schiller AG Altgasse 68 Baar Zug,  CH 6341
ContactSabina Standiford
CorrespondentRay Kelly
Arazy Group Consultants Inc. 68 Southwood Terrace Southbury,  CT  06488
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-11
Decision Date2020-03-02

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