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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 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.

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. 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.

Other records listing Medicalgorithmics S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DSI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK192732BodyGuardian Remote Monitoring SystemPreventice Technologies, Inc.

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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