(29 days)
The Ocu-Film Tip Cover is intended to be used to protect the Tono-Pen transducer from dust and fluids, and helps protect patients from risk of cross-contamination.
Ocu-Film Tip Cover
The provided document is a 510(k) clearance letter from the FDA for a device called "Ocu-Film Tip Cover." This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the Ocu-Film Tip Cover is substantially equivalent to legally marketed predicate devices and is intended to protect Tono-Pen transducers from dust and fluids, and to help protect patients from the risk of cross-contamination.
Therefore, I cannot provide the requested information because it is not present in the provided text.
§ 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.