(352 days)
Replacement battery for Site Micro Surgical Systems (Keeler Optical) 1919-P-5020 Medic Lux 1919-P-5020, 510(k) Number K832437.
This battery is shipped only to customers who request a replacement battery for a particular device or to the biomedical equipment technician therefore knows the intended use is as a replacement battery.
Rechargeable Batteries (Part Numbers Trade Name: MS401097-17, MS720, MS721, MS722, and MS722-K)
This document is a 510(k) clearance letter from the FDA for rechargeable batteries (Trade Name: MS401097-17, MS720, MS721, MS722, and MS722-K). It declares the substantial equivalence of these devices to legally marketed predicate devices.
The provided document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria for a medical device that would typically involve performance metrics like sensitivity, specificity, or reader studies.
The letter focuses on regulatory clearance based on substantial equivalence to existing devices, not on a detailed analysis of performance metrics. Therefore, I cannot generate the requested information based on the input document.
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.