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510(k) Data Aggregation
K Number
K013259Device Name
PORTABLE NON-CONTACT TONOMETER, MODEL PT100Manufacturer
Date Cleared
2002-02-20
(142 days)
Product Code
Regulation Number
886.1930Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
LEICA MICROSYSTEMS, INC. O.I.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The PT100 is a hand held non contact tonometer intended to measure the intraocular pressure of the eye.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter for the Reichert PT100 Portable Tonometer. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.
Therefore, I cannot provide the requested information based on the provided text.
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