Evomatic 8000/4000

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K843815 ↗

FDA Product Code

GWF

Device Class

Class II

Regulation

21 CFR Part 882.1870

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Dantec 13L40 St. Marks's Pudendal Electrode

  Class II

  FDA 510(k) K874758 Active Cleared 14 Apr 1988

• Dantec Counterpoint

  Class II

  FDA 510(k) K872106 Active Cleared 10 Sep 1987

• Sensory Needle Electrode Dne 111-115, 116-117, 118

  Class II

  FDA 510(k) K894911 Active Cleared 14 May 1990

• Dantec Magnetic Stimulator

  Class II

  FDA 510(k) K881915 Active Cleared 17 Oct 1988

• 13L81 Disposable Sphincter Electrode, 13L33 Cable

  Class II

  FDA 510(k) K874759 Active Cleared 14 Apr 1988

• Dantec 22K60/61/62 Catheter Tip Transducer

  Class II

  FDA 510(k) K884915 Active Cleared 4 Oct 1989

See all devices from Dantec Electronics, Inc. →