Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Portable ECG Monitor (ECG3)

K-Number: K172862 · 2018-07-24

ApplicantAndon Health Co, Ltd.
Decision Date2018-07-24
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Portable ECG Monitor (ECG3) is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2018-07-24 under approval number K172862. 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 Portable ECG Monitor (ECG3)?

Portable ECG Monitor (ECG3) is a medical device that received FDA 510(k) clearance on 2018-07-24. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K172862.

When was Portable ECG Monitor (ECG3) approved by the FDA?

Portable ECG Monitor (ECG3) received FDA 510(k) clearance on 2018-07-24, under approval number K172862.

What company makes Portable ECG Monitor (ECG3)?

Portable ECG Monitor (ECG3) is manufactured by Andon Health Co, Ltd..

What is the FDA product code for Portable ECG Monitor (ECG3)?

The FDA product code for Portable ECG Monitor (ECG3) is DSH.

Related Clinical Trials

NCT05452226 Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia COMPLETED NCT05673408 NIBP Validation Study RECRUITING NCT06589700 B2AD-Risk AFDAS Evolution of Burden of AF RECRUITING NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING NCT07508670 An Observational Study of the NeuroBell EEG Monitor COMPLETED

Other Devices by Andon Health Co, Ltd.

K153286iHealth Align Gluco-Monitoring system K153278Wireless Smart Gluco-Monitoring System K160565Fully Automatic Electronic Blood Pressure Monitor K160563Fully Automatic Electronic Blood Pressure Monitor K160014iHealth Track Blood Pressure Monitor K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

View all 31 devices →

Related Devices (Code: DSH)

K162571Bioflux SoftwareBiotricity, Inc. K160704myPatch-sDms-Service, LLC K171936Peerbridge Cor(TM) SystemPeerbridge Health, Inc. K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc. K163535my Patch slDms-Service, LLC K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL

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.

↑