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510(k) K841790

LIFESCAN EEG MONITOR by Neurometrics — Product Code OLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1984
Date Received
April 30, 1984
Clearance Type
Traditional
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.

Other clearances by Neurometrics

  • K861900 — LIFESCAN EVOKED POTENTIAL SYSTEM (August 25, 1986)
  • K800452 — NEUROMETRICS MONITOR (April 2, 1980)

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