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510(k) K904294

QSI 9500 by Quantified Signal Imaging, Inc. — Product Code OLU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1991
Date Received
September 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.

Other clearances by Quantified Signal Imaging, Inc.

  • K894560 — QSI 9000 (August 8, 1990)
  • K863650 — QUANTIMAP III (September 26, 1986)

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