Product Classification

• Device: system, measurement, blood-pressure, non-invasive
• Regulation Description: Noninvasive blood pressure measurement system.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DXN
• Submission Type: 510(k)
• Regulation Number: 870.1130
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/( Manual, electronic or automated sphygmomanometers
• AAMI/ANSI/IEC 80601-2-30:2009 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
• AAMI/ANSI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
• ISO 81060-2 First edition 2009-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
• IEC 80601-2-30 Edition 1.0 2009-1 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
• IEC 80601-2-30 (First edition -2009) Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers CORRIGENDUM 1

Guidance Document

• Non-Invasive Blood Pressure (NIBP) Monitor Guidance

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.