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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tonometer, analyzer, ocular blood flow
Regulation Description Tonometer and accessories.
Definition Tonometry for measuring and recording intraocular pressures and intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, pulsatility index equivalent. Description of why current product c lassificaiton name/product code will not suffice: This device measures intraocular pressure, which is what a tonometer does. However, because it can measure the small changes in pressure caused by the blood pressure pulse in the ocular arterial vessels, it is also capable of measuring and calculating parameters associated with the ocular blood flow, including intraocular pressure pulse amplitude, pulsatile ocular blood flow, and pulsatile ocular blood volume.
Product CodeNJJ
Regulation Number 886.1930
Device Class 2

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