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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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870.11306
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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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||
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标准类型
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采用旧版标准
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采用新版标准
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通用标准
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IEC 60601-1:1988/A1:1991/A2:1995
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IEC 60601-1:2005
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专用标准 +
临床要求
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ANSI/AAMI SP10:2002/ A2:2006/(R)2008
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AAMI/ANSI/IEC 80601-2-30:2009
AAMI/ANSI/ISO 81060-2:2009
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