Disposable EEG cable

510(k) Number

K213884 ↗

FDA product code

GXY

Device class

Class II

Regulation

21 CFR Part 882.1320

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

• TARGET STERILE ELECTRODE by Vision Quest Industries, Inc.
• PRECISION CAP STRAPS by Precision Cap Systems
• BIS QUATRO SENSOR by Aspect Medical Systems, Inc.
• ELECTRO-CAP SYSTEM by ELECTRO-CAP INTL., INC.
• SELF-ADHESIVE ELECTRODES by PAIN MANAGEMENT TECHNOLOGIES
• MODEL 1240, SMALL E NET by Physiometrix, Inc.
• Electrode 13E200=60 by Otto Bock Healthcare Products GmbH
• 'POLYSTIM' by Medical Science Products, Inc.
• GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE by Ives EEG Solutions
• DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE by Covidien llc

• Disposable Temperature Probe

  Class II

  FDA 510(k) K193625 Active Cleared 24 Jul 2020

• Disposable SpO2 Sensor

  Class II

  FDA 510(k) K200069 Active Cleared 13 Mar 2020

• Disposable NIBP Cuff

  Class II

  CE/MDR FDA 510(k) K193629 Active Cleared 25 Mar 2020

• Reusable NIBP Cuff

  Class II

  CE/MDR FDA 510(k) K191253 Active Cleared 17 Sep 2019

See all devices from Shenzhen Changke Connect Electronics Co., Ltd. →