Product Classification

• Device: detector and alarm, arrhythmia
• Regulation Description: Arrhythmia detector and alarm (including ST-segment measurement and alarm).
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DSI
• Submission Type: 510(k)
• Regulation Number: 870.1025
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• AAMI/ANSI EC53:1995/(R) 2008 ECG cables and leadwires
• AAMI/ANSI EC57:1998/(R) 2008 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms

Guidance Document

• Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm  

Third Party Review

Not Third Party Eligible