FDA 510(k)

ECG recorder and Arrhythmia Detector

K-Number: K173461 · 2018-08-03

ApplicantSmart Solutions Technologies SL

Decision Date2018-08-03

Product CodeDSH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ECG recorder and Arrhythmia Detector is a medical device manufactured by Smart Solutions Technologies SL. It received FDA 510(k) clearance on 2018-08-03 under approval number K173461. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG recorder and Arrhythmia Detector?

ECG recorder and Arrhythmia Detector is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by Smart Solutions Technologies SL. The 510(k) number is K173461.

When was ECG recorder and Arrhythmia Detector approved by the FDA?

ECG recorder and Arrhythmia Detector received FDA 510(k) clearance on 2018-08-03, under approval number K173461.

What company makes ECG recorder and Arrhythmia Detector?

ECG recorder and Arrhythmia Detector is manufactured by Smart Solutions Technologies SL.

What is the FDA product code for ECG recorder and Arrhythmia Detector?

The FDA product code for ECG recorder and Arrhythmia Detector is DSH.

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Official Source

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