VICOR PD2I ANALYZER

Electrocardiograph

VICOR TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Vicor Technologies, Inc. with the FDA for Vicor Pd2i Analyzer.

Pre-market Notification Details

Device IDK101867
510k NumberK101867
Device Name:VICOR PD2I ANALYZER
ClassificationElectrocardiograph
Applicant VICOR TECHNOLOGIES, INC. 261 MADISON AVE. 24TH FLOOR New York,  NY  10016
ContactGlen Park
CorrespondentGlen Park
VICOR TECHNOLOGIES, INC. 261 MADISON AVE. 24TH FLOOR New York,  NY  10016
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-02
Decision Date2011-04-14
Summary:summary

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