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U.S. Department of Health and Human Services

Product Classification

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Device single lead over-the-counter electrocardiograph
Regulation Description Electrocardiograph.
Definition Devices are intended to record and analyze single-lead electrocardiograms. Devices only display interval values to the user. Devices are intended for over-the-counter sale. Devices are indicated for users who wish to monitor common ECG intervals.
Physical State Battery-operated, Plastic Case, Metal electrodes, Liquid Crystal Display
Technical Method Records single-lead electrocardiogram through two or three electrodes. Automatically analyzes waveform for common, clinically-accepted intervals.
Target Area heart
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOEY
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible