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U.S. Department of Health and Human Services

Product Classification

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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.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeNJJ
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(k)
Regulation Number 886.1930
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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