# K991199: Biopotential Skin Electrode, Models Bme 300, Bme 200, Bme 100, Bme 150

- Pathway: 510(k) (Traditional)
- Applicant: Biomed Products
- Decided: Jun 22, 1999 after 75 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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 Electro-oculographs (EOG).

Source page: https://510kreport.com/device/K991199
Methodology: https://510kreport.com/methodology