MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM

Detector And Alarm, Arrhythmia

MEDICALGORITHMICS S.A.

The following data is part of a premarket notification filed by Medicalgorithmics S.a. with the FDA for Medicalgorithmics Unified Arrhythmia Diagnosic System.

Pre-market Notification Details

Device IDK152550
510k NumberK152550
Device Name:MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
ClassificationDetector And Alarm, Arrhythmia
Applicant MEDICALGORITHMICS S.A. AI. JEROZOLIMSKIE 81 Warsaw,  PL 02-001
ContactMarek J. Dziubinski
CorrespondentMartin Jasinski
MEDICALGORITHMICS LLC. 245 WEST 107TH STREET SUITE 11 A New York,  NY  10025
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-08
Decision Date2015-10-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05903021560025 K152550 000

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