Product Classification

• Device: system, network and communication, physiological monitors
• Regulation Description: Cardiac monitor (including cardiotachometer and rate alarm).
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: MSX
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: 510(k)
• Regulation Number: 870.2300
• 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

• 13-56 IEEE Std 11073-10406-2011
  Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
• 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
• 13-120 ANSI AAMI 2700-1:2019
  Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
• 13-147 IEEE Std 11073-10406-2023
  Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)

Third Party Review

Not Third Party Eligible