Fastrace III ECG Electrode

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

510(k) Number

K860636 ↗

FDA Product Code

DPS

Device Class

Class II

Regulation

21 CFR Part 870.2340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K905729 Active Cleared 7 Feb 1991

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  Class II

  FDA 510(k) K944849 Active Cleared 17 Oct 1994

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• What is the Fastrace III ECG electrode used for?

  The Fastrace III ECG electrode is designed for cardiovascular monitoring, serving as a conductive interface to detect and record electrical signals from the heart during electrocardiography procedures.

• Who manufactures the Fastrace III ECG electrode and what is its regulatory status?

  The Fastrace III ECG electrode is manufactured by Andover Medical, Inc. and has received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device.

• What product code and regulation number apply to the Fastrace III ECG electrode?

  The Fastrace III ECG electrode is categorized under product code DPS and regulation number 870.2340, which governs its classification within the cardiovascular monitoring device family.