KOWA HAND-HELD APPLANATION TONOMETER HA-1

• K Number: K960924
• Device Name: KOWA HAND-HELD APPLANATION TONOMETER HA-1
• Manufacturer: KOWA OPTIMED, INC.
• Date Cleared: 1996-06-04 ( 90 days)
• Product Code: HKY
• Regulation Number: 886.1930

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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