BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150

• K Number: K991199
• Device Name: BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150
• Manufacturer: BIOMED PRODUCTS
• Date Cleared: 1999-06-22 ( 75 days)
• Product Code: GXY , AND , BWY , IKA
• Regulation Number: 882.1320
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

BioMed Products biopotential skin electrode will be used by the Bio Medical Community for the acquisition of all surface biopotentials, i.e. Electroencephalographs (EEG), Electromyographs (EMG), and Electrooculographs (EOG).

Device Description

Biopotential Skin Electrode

AI/ML Overview

The provided document is a 510(k) clearance letter for a medical device (Biopotential Skin Electrode). It does not contain any information regarding acceptance criteria related to device performance or a study proving its conformance to such criteria.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, not a demonstration of specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study proving the device meets them based on the provided text. The document is administrative in nature, detailing regulatory clearance, and does not include scientific study results or performance data.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).