Product Classification

• Device: monitor, cardiac (incl. cardiotachometer & rate alarm)
• Regulation Description: Cardiac monitor (including cardiotachometer and rate alarm).
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DRT
• Submission Type: 510(k)
• Regulation Number: 870.2300
• 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
• AAMI/ANSI/IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
• AAMI/ANSI EC13:2002/(R)2007 Cardiac monitors, heart rate meters, and alarms

Guidance Document

• Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm); Final

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.