510(k) K081551

TWIN NEUROTRAC-III by Astro-Med, Inc. — Product Code OMA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 24, 2008
Date Received: June 3, 2008
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Amplitude-Integrated Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).

Other clearances by Astro-Med, Inc.

K050425 — AURA-PSG (October 20, 2005)
K033978 — ADAM (February 18, 2004)
K970951 — GRASS BRAINWAVE SOFTWARE (May 19, 1997)
K963669 — GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM (December 12, 1996)
K934644 — K3 SYSTEM (November 1, 1994)
K912929 — DASH IV (August 13, 1991)
K896164 — ASC-954 INTEGRATOR AMPLIFIER (January 22, 1990)
K894295 — ASTRO-MED ASC-951 PRESSURE PROCESSOR (January 18, 1990)
K894736 — MT96000 PAPER CHART RECORDER (December 13, 1989)
K894735 — ASC-952 PHYSIOLOGICAL AMPLIFIER (September 18, 1989)

Other clearances for product code OMA

K192889 — Neo (January 30, 2020)
K163644 — Nihon Kohden QP-160AK EEG Trend Program (May 19, 2017)
K161027 — Cadwell AmpliScan (November 8, 2016)
K152301 — Background Pattern Classification [BPc(TM)] (June 3, 2016)
K130238 — NIHON KOHDEN AE-918P NEURO UNIT (March 4, 2015)
K131789 — CEREBRALOGIK- AEEG (December 27, 2013)
K123079 — OLYMPIC BRAINZ MONITOR (May 8, 2013)
K120485 — NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AN (March 16, 2012)
K092573 — NIHON KOHDEN QP-160AK EEG TREND PROGRAM (July 9, 2010)
K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001 (June 16, 2010)