Product Classification

• Device: electrocardiograph
• Regulation Description: Electrocardiograph.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DPS
• Submission Type: 510(k)
• Regulation Number: 870.2340
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• AAMI/ANSI EC11:1991/(R)2007 Diagnostic electrocardiographic devices
• 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
• 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, edition 3.0
• 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
• 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
• AAMI/ANSI/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

Guidance Document

• Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); 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.