Dantec 13R45 Bar Electrode

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K934580 ↗

FDA Product Code

GXY

Device Class

Class II

Regulation

21 CFR Part 882.1320

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Dantec Disposable Concentric Needle

  Class II

  FDA 510(k) K931966 Active Cleared 30 Mar 1994

• Dantec Electrodes Model Dne 116, 117 & 13P02/12

  Class II

  FDA 510(k) K896874 Active Cleared 18 Jun 1990

• Cantata EMG/Evoked Response System

  Class II

  FDA 510(k) K896567 Active Cleared 16 Feb 1990

• Dantec Menuet

  Class II

  FDA 510(k) K912701 Active Cleared 9 Dec 1991

• Cavernosometry Module for Menuet

  Class II

  FDA 510(k) K923117 Active Cleared 22 Feb 1993

• Dantec Magnetic Stimulator Mag 2 (Mag 2)

  Class II

  FDA 510(k) K902607 Active Cleared 14 May 1991

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