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Dantec Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
25
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K960503DANTEC DUETSeptember 16, 1996
K950314DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)March 25, 1996
K953999DANTEC DA CAPONovember 21, 1995
K926363MULTI-DOP SJune 19, 1995
K931801MULTI-DOP XJune 14, 1995
K930458MULTI-DOP LFebruary 3, 1995
K932059NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODEOctober 4, 1994
K934580DANTEC 13R45 BAR ELECTRODESeptember 26, 1994
K931966DANTEC DISPOSABLE CONCENTRIC NEEDLEMarch 30, 1994
K931923DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)November 9, 1993
K926516DANTEC MAGNETIC STIMULATOR MAGPROAugust 31, 1993
K924127DANTEC EVOLUTIONMarch 10, 1993
K923117CAVERNOSOMETRY MODULE FOR MENUETFebruary 22, 1993
K915741DISPOSABLE MONOPLAR MEDDLE ELECTRODESDecember 8, 1992
K913957DANTEC COUNTERPOINT MK2(TM)January 30, 1992
K913169DANTEC UD 5500 MK2January 23, 1992
K914891PULLER OPTION FOR ETUDE(TM)January 7, 1992
K912701DANTEC MENUETDecember 9, 1991
K911229PHOENIX DIGITAL EEG SYSTEMSeptember 30, 1991
K913323ETUDE (MODEL NUMBERS 24A05 & 24A06)September 23, 1991