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K Number
K955577
Device Name
ECLIPSE VERSION 3.0
Manufacturer
STELLATE SYSTEMS
Date Cleared
1996-09-20

(317 days)

Product Code
OLT,OLV
Regulation Number
882.1400
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information regarding the acceptance criteria, study details, or device performance for "Eclipse Version 3.0" (Trade/Device Name: Eclipse Version 3.0, K955577). The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device.

Therefore, I cannot provide the requested table and information.

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).