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U.S. Department of Health and Human Services

Product Classification

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Device multivariate vital signs index
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Definition Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.
Physical State software/firmware
Technical Method Collects measured parameter inputs and automates the calculation of a summary index based on those parameters
Target Area Various
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePLB
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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