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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 the device name listed in this FDA 510(k) record. The listed applicant is Smart Solutions Technologies SL. It received FDA 510(k) clearance on 2018-08-03 under 510(k) 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. The listed applicant is Smart Solutions Technologies SL. The 510(k) number is K173461.

When did ECG recorder and Arrhythmia Detector receive FDA 510(k) clearance?

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

Who is the listed applicant for ECG recorder and Arrhythmia Detector?

The FDA 510(k) record lists Smart Solutions Technologies SL as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Smart Solutions Technologies SL 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.

K231620Nuubo Smart

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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