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K Number
K994011
Device Name
EP MEDSYSTEMS, EP-WORKMATE
Manufacturer
EP MEDSYSTEMS, INC.
Date Cleared
2000-03-23

(118 days)

Product Code
DQK
Regulation Number
870.1425
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EP-WorkMate® Computerized Electrophysiology Recording System is intended for use during clinical electrophysiology procedures.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding 510(k) clearance for a device named "EP WorkMate Computerized Electrophysiology Recording System". It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.

However, this document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot fulfill your request to describe these aspects of a study.

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).