Product Classification

• Device: dc-defibrillator, low-energy, (including paddles)
• Regulation Description: DC-defibrillator (including paddles).
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: LDD
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: 510(k)
• Regulation Number: 870.5300
• 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?: Yes

Recognized Consensus Standards

• 3-129 ANSI AAMI EC53:2013/(R)2020
  ECG trunk cables and patient leadwires
• 3-169 IEC 60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION
  Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

Third Party Review

Not Third Party Eligible