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510(k) Data Aggregation
K Number
K041442Device Name
EP-4 CLINICAL STIMUTATORManufacturer
Date Cleared
2004-09-14
(105 days)
Product Code
Regulation Number
870.1750Type
SpecialPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
EP-4 CLINICAL STIMUTATOR
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.
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