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K Number
K010998
Device Name
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
Manufacturer
LANGHAM OPHTHALMIC TECHNOLOGIES
Date Cleared
2001-06-27

(85 days)

Product Code
HKX
Regulation Number
886.1930
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
Predicate For
K071755
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Langham Ocular Blood Flow (OBF) Model 201 measures the intraocular pressure and the pulse amplitude.

Device Description

Langham Ocular Blood Flow (OBF) Model 201 Tonograph/Tonometer

AI/ML Overview

This document is a 510(k) clearance letter for the Langham Ocular Blood Flow (OBF) Model 201 Tonograph/Tonometer. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily addresses the substantial equivalence determination to a predicate device and outlines regulatory requirements and labeling limitations.

Therefore, I cannot provide the requested information.

§ 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.