Product Classification

• Device: electrocardiograph software for over-the-counter use
• Regulation Description: Electrocardiograph software for over-the-counter use.
• Definition: An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.
• Physical State: The devices uses consumer grade electronics and is hand held or worn on the wrist, arms, or chest.
• Technical Method: Uses input from leads attached to or in contact with the users hands, wrists, arms, or chest to detect potential differences and generate an ECG waveform.
• Target Area: Hands, arms, or chest.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: QDA
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: 510(k)
• Regulation Number: 870.2345
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible