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FDA 510(k)

MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM

K-Number: K112921 · 2012-05-16

ApplicantMedicalgorithmics S.A.
Decision Date2012-05-16
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM 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 2012-05-16 under 510(k) number K112921. 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 MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM?

MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-16. The listed applicant is Medicalgorithmics S.A.. The 510(k) number is K112921.

When did MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 2012-05-16, under 510(k) number K112921.

Who is the listed applicant for MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM?

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 MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM?

The FDA product code for MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM is DSI.

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Other records listing Medicalgorithmics S.A. as applicant

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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.

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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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