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1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Tonometer, Analyzer, Ocular Blood Flow

Device class

Class II (moderate risk)

Regulation

21 CFR 886.1930

Medical specialty

Ophthalmic

Flags

Third-party review eligible

FDA 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.

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