EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)

• K Number: K991903
• Device Name: EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
• Manufacturer: EXCEL TECH. LTD.
• Date Cleared: 1999-08-04 ( 61 days)
• Product Code: GWE
• Regulation Number: 882.1890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

Excel "Photic Stimulator" is intended The photic activation of the EEG in visual evoked potentials.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Excel Photic Stimulator." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device has been cleared for marketing based on its substantial equivalence to a legally marketed predicate device.

Therefore, I cannot extract the requested information from the provided text.

Regulation Number and Section

§ 882.1890 Evoked response photic stimulator.

(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).