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K Number
K041442
Device Name
EP-4 CLINICAL STIMUTATOR
Manufacturer
EP MEDSYSTEMS
Date Cleared
2004-09-14

(105 days)

Product Code
JOQ
Regulation Number
870.1750
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions.

Device Description

Not Found

AI/ML Overview

I am sorry. I cannot answer your question. The document does not describe the acceptance criteria, the study details, or the performance of the device. It is a 510(k) clearance letter and an "Indications for Use" statement for a medical device called the "EP-4 Clinical Stimulator." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its intended uses.

§ 870.1750 External programmable pacemaker pulse generator.

(a)
Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.(b)
Classification. Class II (performance standards).