CARDIOVIT AT-10PLUS

Electrocardiograph

SCHILLER AG

The following data is part of a premarket notification filed by Schiller Ag with the FDA for Cardiovit At-10plus.

Pre-market Notification Details

Device IDK050686
510k NumberK050686
Device Name:CARDIOVIT AT-10PLUS
ClassificationElectrocardiograph
Applicant SCHILLER AG ALTGASSE 68 Baar,  CH Ch-6341
ContactMarkus Buetler
CorrespondentMarkus Buetler
SCHILLER AG ALTGASSE 68 Baar,  CH Ch-6341
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-16
Decision Date2005-05-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613365000054 K050686 000

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