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FDA 510(k)

Unified Arrhythmia Diagnostic System PocketECG IV

K-Number: K193104 · 2020-04-09

ApplicantMedicalgorithmics S.A.
Decision Date2020-04-09
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Unified Arrhythmia Diagnostic System PocketECG IV is a medical device manufactured by Medicalgorithmics S.A.. It received FDA 510(k) clearance on 2020-04-09 under approval number K193104. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unified Arrhythmia Diagnostic System PocketECG IV?

Unified Arrhythmia Diagnostic System PocketECG IV is a medical device that received FDA 510(k) clearance on 2020-04-09. It is manufactured by Medicalgorithmics S.A.. The 510(k) number is K193104.

When was Unified Arrhythmia Diagnostic System PocketECG IV approved by the FDA?

Unified Arrhythmia Diagnostic System PocketECG IV received FDA 510(k) clearance on 2020-04-09, under approval number K193104.

What company makes Unified Arrhythmia Diagnostic System PocketECG IV?

Unified Arrhythmia Diagnostic System PocketECG IV is manufactured by Medicalgorithmics S.A..

What is the FDA product code for Unified Arrhythmia Diagnostic System PocketECG IV?

The FDA product code for Unified Arrhythmia Diagnostic System PocketECG IV is DSI.

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Related PubMed Literature

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Other Devices by Medicalgorithmics S.A.

K173969Medicalgorithmics Unified Cardiac Rehabilitation System K210822DeepRhythmAI K210758Q Patch K241197DeepRhythmAI K232161DeepRhythm Platform K253141DeepRhythmAI

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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