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510(k) K020218

SNAP EEG MONITOR by Nicolet Biomedical, Inc. — Product Code OLW

K020218 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical, Inc. for the device "SNAP EEG MONITOR". The FDA issued a decision of Substantially Equivalent on April 22, 2002. The device falls under product code OLW (Index-Generating Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Nicolet Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2002
Date Received
January 22, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Index-Generating Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a 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)
  • 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)
  • K010019 — STERILE SUBDERMAL NEEDLE ELECTRODES (March 19, 2001)

Other clearances for product code OLW

  • K260880 — SedLine Sedation Monitor (July 10, 2026)
  • K230693 — BIS™ Advance Monitoring System (February 26, 2024)
  • K213273 — Brain Anesthesia Response Monitor (Bar Monitor) (September 1, 2023)
  • K203113 — Masimo SedLine Sedation Monitor and Accessories (February 25, 2022)
  • K202621 — NeuroSENSE Monitoring System, Model NS-901 (August 5, 2021)
  • K172890 — SedLine Sedation Monitor (January 26, 2018)
  • K150298 — Entropy Module, E-ENTROPY-01 (November 12, 2015)
  • K083063 — BIS INTERFACE FOR VITALOGIK PATIENT MONITORS (December 16, 2008)
  • K061907 — MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES (March 27, 2008)
  • K072286 — BIS EEG VISTA MONITOR SYSTEM AND BISX (November 20, 2007)

FDA data resources