510(k) K080546

NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A by Nihon Kohden America, Inc. — Product Code OLT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 29, 2008
Date Received: February 28, 2008
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Non-Normalizing Quantitative Electroencephalograph Software
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

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K080342 — NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES (February 26, 2008)
K073491 — EEG-1100A SWITCH BOX (January 11, 2008)

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