Product Classification

• Device: electrocardiograph
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DPS
• 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 3-105 IEC 60601-2-25 Edition 2.0 2011-10
  Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
• 3-118 ANSI AAMI EC57:2012
  Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
• 3-126 IEC 60601-2-27 Edition 3.0 2011-03
  Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
• 3-129 ANSI AAMI EC53:2013/(R)2020
  ECG trunk cables and patient leadwires
• 13-56 IEEE Std 11073-10406-2011
  Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph
• 13-75 ISO IEEE 11073-10102 First edition 2014-03-01
  Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
• 13-76 ISO 11073-91064 First edition 2009-05-01
  Health informatics - Standard communication protocol - Computer-assisted electrocardiography
• 13-89 ISO IEEE 11073-10406 First edition 2012-12-01
  Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock ventures
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc