Product Classification

• Device: electrocardiograph, ambulatory, with analysis algorithm
• Regulation Description: Medical magnetic tape recorder.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: MLO
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: 510(k)
• Regulation Number: 870.2800
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 3-118 ANSI AAMI EC57:2012
  Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
• 3-129 ANSI AAMI EC53:2013/(R)2020
  ECG trunk cables and patient leadwires
• 3-155 IEC 60601-2-47 Edition 2.0 2012-02
  Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems

Third Party Review

Not Third Party Eligible