Q Patch

Recorder, Magnetic Tape, Medical

Medicalgorithmics S.A.

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

Pre-market Notification Details

Device IDK210758
510k NumberK210758
Device Name:Q Patch
ClassificationRecorder, Magnetic Tape, Medical
Applicant Medicalgorithmics S.A. Aleje Jerozolimskie 81 Warsaw,  PL 02-001
ContactMarek Dziubinski
CorrespondentAgnieszka Romowicz
Medicalgorithmics US Holding Corporation Corporation Service Company 251 Little Falls Drive Wilmington,  DE  19808
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-15
Decision Date2022-06-02

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