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510(k) Data Aggregation
K Number
K010998Manufacturer
Date Cleared
2001-06-27
(85 days)
Product Code
Regulation Number
886.1930Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
Predicate For
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.
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