EKGCARD SYSTEM

Electrocardiograph

QRS DIAGNOSTIC, LLC.

The following data is part of a premarket notification filed by Qrs Diagnostic, Llc. with the FDA for Ekgcard System.

Pre-market Notification Details

Device IDK030535
510k NumberK030535
Device Name:EKGCARD SYSTEM
ClassificationElectrocardiograph
Applicant QRS DIAGNOSTIC, LLC. 14755 27TH AVE.NORTH Plymouth,  MN  55447
ContactBrad Sorenson
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-02-20
Decision Date2003-06-11
Summary:summary

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