FDA product code for noninvasive blood pressure measurements:
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Device
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system, measurement, blood-pressure, non-invasive
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Regulation Description
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Noninvasive blood pressure measurement system.
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Regulation Medical Specialty
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Cardiovascular
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Review Panel
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Cardiovascular
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Product Code
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DXN
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Submission Type
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510(k)
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Regulation Number
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< font size = "2" > 870.1130 < / font > < font size = "2" > < sup > 6 < / sup > < / font > < / div >
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Device Class
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2
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Total Product Life Cycle (TPLC)
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TPLC Product Code Report7
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GMP Exempt?
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No
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Recognized Consensus Standards
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SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/( Manual, electronic or automated sphygmomanometers8
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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 sphygmomanometers9
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AAMI/ANSI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type10
· ISO 81060-2 First edition 2009-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type11
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Because the FDA has not yet mandated Version 3 of the standard, both the old standard (ANSI/AAMI SP10) and the Standard (Version 2) will be accepted for electronic sphygmomanometer or blood pressure monitoring devices until June 30, 2013.
The current standard detection combination reference is as follows:
General standard and specific standard for electronic sphygmomanometer and blood pressure monitoring equipment based on the measurement principle of oscillation method
