Medical Device Manufacturer · US , Mahwah , NJ

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

25 submissions · 25 cleared · Since 1990

Recent clearances: DANTEC DUET, DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19), DANTEC DA CAPO

25

Total

25

Cleared

0

Denied

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

13 devices

1-13 of 13

Cleared Mar 25, 1996

DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)

Neurology · 424d

Cleared Oct 04, 1994

NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE

Neurology · 523d

Cleared Sep 26, 1994

DANTEC 13R45 BAR ELECTRODE

Neurology · 368d

Cleared Mar 30, 1994

DANTEC DISPOSABLE CONCENTRIC NEEDLE

Neurology · 343d

Cleared Nov 09, 1993

DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)

Neurology · 207d

Cleared Aug 31, 1993

DANTEC MAGNETIC STIMULATOR MAGPRO

Neurology · 244d

Cleared Mar 10, 1993

DANTEC EVOLUTION

Neurology · 205d

Cleared Dec 08, 1992

DISPOSABLE MONOPLAR MEDDLE ELECTRODES

Neurology · 354d

Cleared Jan 30, 1992

DANTEC COUNTERPOINT MK2(TM)

Neurology · 148d

Cleared Sep 30, 1991

PHOENIX DIGITAL EEG SYSTEM

Neurology · 194d

Cleared May 14, 1991

DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)

Neurology · 336d

Cleared Jun 18, 1990

DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12

Neurology · 192d

Cleared Feb 16, 1990

CANTATA EMG/EVOKED RESPONSE SYSTEM

Neurology · 88d