CARDIOVIT FT-1

Electrocardiograph

SCHILLER AG

The following data is part of a premarket notification filed by Schiller Ag with the FDA for Cardiovit Ft-1.

Pre-market Notification Details

Device IDK170182
510k NumberK170182
Device Name:CARDIOVIT FT-1
ClassificationElectrocardiograph
Applicant SCHILLER AG ALTGASSE 68 Baar,  CH Ch-6371
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 Received2017-01-23
Decision Date2017-07-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613365002003 K170182 000
07613365002027 K170182 000
07613365003789 K170182 000
07613365003642 K170182 000
07613365002867 K170182 000
07613365000184 K170182 000
07613365001969 K170182 000
07613365001976 K170182 000
07613365001983 K170182 000
07613365001990 K170182 000
07613365002225 K170182 000

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