Medical Device Manufacturer · US , Walker , MI

Dantec Electronics, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1985

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dantec Electronics, Inc. Neurology ✕

7 devices

1-7 of 7

Cleared Jun 18, 1990

CONCENTRIC ELECTRODE TYPE #13R01, 13R02

Neurology · 285d

Cleared May 14, 1990

SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118

Neurology · 286d

Cleared Oct 17, 1988

DANTEC MAGNETIC STIMULATOR

Neurology · 161d

Cleared Jan 22, 1988

DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE

Neurology · 65d

Cleared Oct 06, 1987

Neurology · 238d

Cleared Sep 10, 1987

DANTEC COUNTERPOINT

Neurology · 101d

Cleared May 31, 1985

EVOMATIC 8000/4000

Neurology · 245d