Diagnostic Station DS20

Electrocardiograph

SCHILLER AG

The following data is part of a premarket notification filed by Schiller Ag with the FDA for Diagnostic Station Ds20.

Pre-market Notification Details

Device IDK152043
510k NumberK152043
Device Name:Diagnostic Station DS20
ClassificationElectrocardiograph
Applicant SCHILLER AG ALTGASSE 68 Baar,  CH Ch-6341
ContactZhenrong Yu
CorrespondentJim Chickering
ZOE MEDICAL, INC. 460 BOSTON STREET Topsfield,  MA  01983
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-23
Decision Date2016-05-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613365001808 K152043 000
07613365000474 K152043 000
07613365000481 K152043 000
07613365000498 K152043 000
07613365001754 K152043 000
07613365001761 K152043 000
07613365001778 K152043 000
07613365001785 K152043 000
07613365001792 K152043 000
07613365000467 K152043 000

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