ECG Electrode

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K944655 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Direct Current Bone Growth Stim. an. Pad

  Not classified

  FDA 510(k) K810271 Active Cleared 19 Feb 1981

• Canmed 451

  Class II

  FDA 510(k) K905729 Active Cleared 7 Feb 1991

• 2700 Cleartrace Radiotranslucent Monitoring ECG Electrobe

  Class II

  FDA 510(k) K944849 Active Cleared 17 Oct 1994

• Modified Label Change to Model 5455 Surgical Cable

  Class II

  FDA 510(k) K885171 Active Cleared 12 Jan 1989

• Holter Kit Model #5000 Series

  Class II

  FDA 510(k) K823414 Active Cleared 30 Dec 1982

• Thermal Dilution Catheter

  Class II

  FDA 510(k) K843411 Active Cleared 18 Oct 1984

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• What is the ECG electrode used for?

  The ECG electrode is used to detect and transmit electrical signals from the heart for electrocardiographic monitoring in clinical settings to acquire ECG data.

• How is the ECG electrode supplied and is it sterile or single-use?

  The device is supplied as a non-sterile, single-use product intended for use in healthcare facilities, meaning it is not provided in a sterile condition and is designed for one-time use only.

• What sizes and configurations are available for the ECG electrode?

  The ECG electrode is available in various sizes and configurations as specified in the product line, though specific dimensions or configurations are not detailed in the provided data.

• What regulatory pathway was used for the ECG electrode's market authorization?

  The device received FDA 510(k) clearance under K944655, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) review process.