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Nicolet Biomedical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K020754NICOLET PIONEER TC8080April 21, 2003
K021986BRAINETAugust 23, 2002
K021144SUBDURAL STRIP ELECTRODEJune 24, 2002
K020218SNAP EEG MONITORApril 22, 2002
K013281VERSALAB APMApril 18, 2002
K020955NICOLET ELECTROCAUTERY DETECTORApril 17, 2002
K013419NICOLET ELECTROMAGNETIC NAVIGATION SYSTEMDecember 20, 2001
K011818STERILE EMG ELECTRODESSeptember 6, 2001
K011823BIOREHAB SYSTEMSeptember 6, 2001
K011135GSI AUDERAJuly 26, 2001
K010019STERILE SUBDERMAL NEEDLE ELECTRODESMarch 19, 2001
K010521NICOLET VERSALABMarch 9, 2001
K002766NICOLET VASOGUARDNovember 30, 2000
K993939NICOLET EME LEGEND TC22June 29, 2000
K991054BRAVO MULTI-MODALITY SYSTEMNovember 3, 1999
K982635CAREDOP IIAugust 7, 1998
K971331SATELLITEJune 25, 1997
K950270NMI SOFTWAREMay 15, 1995