FDA 510(k)

Unified Arrhythmia Diagnostic System PocketECG IV

Número K: K193104 · 2020-04-09

Data da decisão2020-04-09

Código do produtoDSI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Medicalgorithmics S.A.. The 510(k) number is K193104.

When did Unified Arrhythmia Diagnostic System PocketECG IV receive FDA 510(k) clearance?

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

Who is the listed applicant for Unified Arrhythmia Diagnostic System PocketECG IV?

The FDA 510(k) record lists Medicalgorithmics S.A. as the applicant. This does not by itself establish the device manufacturer.

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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