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K Number
K083377
Device Name
ACCUPEN
Manufacturer
ACCUTOME ULTRASOUND, INC.
Date Cleared
2009-07-27

(255 days)

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

The indications for use include measuring intraocular pressure for suspected glaucoma or when an increased intraocular pressure is suspected.

Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria, device performance, or details of any studies conducted for the AccuPen device. The documents are limited to a 510(k) clearance letter and an Indications for Use statement. Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or other study-related details.

§ 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.