NEUROLINK IP, MODEL PK1113

• K Number: K081741
• Device Name: NEUROLINK IP, MODEL PK1113
• Manufacturer: EXCEL-TECH LTD. (XLTEK)
• Date Cleared: 2008-10-31 ( 134 days)
• Product Code: GWQ
• Regulation Number: 882.1400
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The NeuroLink IP system is intended to be used as an electroencephalograph: to acquire, store, display and archive electroencephalographic signals.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "NeuroLink IP, Model PK1113," an electroencephalograph. The letter confirms that the device is substantially equivalent to a legally marketed predicate device.

Unfortunately, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC or standalone).

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• Regulatory classification (Class II).
• General controls and applicable regulations.
• Contact information for various FDA divisions.
• The intended use of the device (to acquire, store, display, and archive electroencephalographic signals).

Therefore, I cannot provide the requested table and detailed information based solely on the provided text. To answer your questions, the original 510(k) submission document would be required, as it typically contains the technical details, performance data, and study methodologies supporting the device's clearance.

Regulation Number and Section

§ 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).