Medical Device Manufacturer · US , Madison , WI

Nicolet Biomedical, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1995

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nicolet Biomedical, Inc. Neurology ✕

9 devices

1-9 of 9

Cleared Aug 23, 2002

Neurology · 66d

Cleared Jun 24, 2002

SUBDURAL STRIP ELECTRODE

Neurology · 76d

Cleared Apr 22, 2002

SNAP EEG MONITOR

Neurology · 90d

Cleared Sep 06, 2001

STERILE EMG ELECTRODES

Neurology · 87d

Cleared Sep 06, 2001

BIOREHAB SYSTEM

Neurology · 87d

Cleared Mar 19, 2001

STERILE SUBDERMAL NEEDLE ELECTRODES

Neurology · 76d

Cleared Nov 03, 1999

BRAVO MULTI-MODALITY SYSTEM

Neurology · 218d

Cleared Jun 25, 1997

Neurology · 76d

Cleared May 15, 1995

Neurology · 112d