(610 days)
The T170 Applanation Tonometer is indicated for Intraocular Pressure (IOP) measurement.
Not Found
This document is an FDA 510(k) clearance letter for an Applanation Tonometer (K142263). It does not contain the acceptance criteria or a study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device but does not detail the pre-clinical or clinical studies conducted by the manufacturer for this specific device.
Therefore, I cannot provide the requested information based on the provided text. To answer your questions, the relevant sections of the 510(k) submission, specifically the performance data and testing summaries, would be required.
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.