Search Results
Found 1 results
510(k) Data Aggregation
K Number
K020903Device Name
DOCXS B SERIES ELECTRODES
Manufacturer
Date Cleared
2002-09-26
(190 days)
Product Code
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
DOCXS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Biopotential skin electrodes will be used by the Bio Medical community in both clinical and research applications of the acquisition of all surface biopotentials, standards, and reference, i.e. Electroencephalograph (EEG), Electrocardiograph (ECG), Electromyography (EMG), Electrooculograph (EOG).
Device Description
This specific device is comprised of a sintered Ag-AgCl electrode with a 99.99% Silver wire. Some of the electrodes are to be sold as bare electrodes. Some are set and sealed in an epoxy or silicone housing with a PVC, Silicone or other TPE insulated, tinseled copper lead wire attached. The device is then sealed with either silicone or Epoxy. They have a smooth, non-porous finish on all surfaces with no cracks, seams, or bubbles. It is then considered waterproof and cold sterilizable. There is a recess in the underside of the housing surrounding the exposed electrode surface to allow for the placement of an electroconductive gel. The gel establishes contact between the Ag-AgCl electrode and the subject surface to be measured. The gel improves electro conductivity between the subject surface and the Ag-AgCl electrode surface for a more sensitive and accurate reading of the Biopotential. The lead wires are either unterminated or terminate with a 1.5 DIN safety socket, snap, or pinch connector.
Ask a Question
Ask a specific question about this device
Page 1 of 1