510(k) K950270

NMI SOFTWARE by Nicolet Biomedical, Inc. — Product Code OMB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 15, 1995
Date Received: January 23, 1995
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Automatic Event Detection Software For Full-Montage Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user

Other clearances by Nicolet Biomedical, Inc.

K020754 — NICOLET PIONEER TC8080 (April 21, 2003)
K021986 — BRAINET (August 23, 2002)
K021144 — SUBDURAL STRIP ELECTRODE (June 24, 2002)
K020218 — SNAP EEG MONITOR (April 22, 2002)
K013281 — VERSALAB APM (April 18, 2002)
K020955 — NICOLET ELECTROCAUTERY DETECTOR (April 17, 2002)
K013419 — NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM (December 20, 2001)
K011818 — STERILE EMG ELECTRODES (September 6, 2001)
K011823 — BIOREHAB SYSTEM (September 6, 2001)
K011135 — GSI AUDERA (July 26, 2001)

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