PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)

• K Number: K060189
• Device Name: PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
• Manufacturer: IVES EEG SOLUTIONS, INC.
• Date Cleared: 2006-05-30 ( 126 days)
• Product Code: GXZ
• Regulation Number: 882.1350
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

The pediatric subdermal wire electrode (pSWE) is intended for temporary recording of EEG in comatose pediatric patients (range: 6 to 21 years) in hospital based Intensive Care Units (ICU).

The pSWE is a disposable, single use device.

The pSWE is intended for use in a similar manner to that of a subdermal needle electrode.

Device Description

Not Found

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device and is a regulatory approval letter. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document only confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for its intended use. It is a registration and approval document, not a clinical trial report or a performance study.

Therefore, I cannot provide the requested information from the given text.

Regulation Number and Section

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).