Universal SmartECG

Electrocardiograph

VectraCor, Inc.

The following data is part of a premarket notification filed by Vectracor, Inc. with the FDA for Universal Smartecg.

Pre-market Notification Details

Device IDK173952
510k NumberK173952
Device Name:Universal SmartECG
ClassificationElectrocardiograph
Applicant VectraCor, Inc. 785 Totowa Rd. Suite 100 Totowa,  NJ  07512
ContactAndrew Schreck
CorrespondentAndrew Schreck
VectraCor, Inc. 785 Totowa Rd. Suite 100 Totowa,  NJ  07512
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-27
Decision Date2018-08-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857175006173 K173952 000

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