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U.S. Department of Health and Human Services

Product Classification

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Device adjunctive cardiovascular status indicator
Definition The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s).This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Physical State Software/Firmware
Technical Method The early warning and physiological status indicator/index matches subject waveforms to known waveforms in an attempt to provide a comprehensive measure of all the changes that are in the PPG waveform. The major assumption is that central blood volume, or more specifically individual tolerance to reduced central blood volume, is the major determinant of the PPG waveform shape. This entry applies to the De Novo for which this procode was created. Future devices under this procode could potentially use different technical methods which still fit the general "intended use" of this classification.
Target Area Various
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePPW
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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