Computer, Diagnostic, Programmable

Medicalgorithmics S.A.

The following data is part of a premarket notification filed by Medicalgorithmics S.a. with the FDA for Deeprhythmai.

Pre-market Notification Details

Device IDK210822
510k NumberK210822
Device Name:DeepRhythmAI
ClassificationComputer, Diagnostic, Programmable
Applicant Medicalgorithmics S.A. Aleje Jerozolimskie 81 Warsaw,  PL 02-001
ContactMarek Dziubinski
CorrespondentAgnieszka Romowicz
Medicalgorithmics US Holding Corporation 2711 Centerville Road, Suite 400 Wilmington,  DE  19808
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-19
Decision Date2022-07-27

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