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510(k) K894560

QSI 9000 by Quantified Signal Imaging, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1990
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Quantified Signal Imaging, Inc.

  • K904294 — QSI 9500 (July 30, 1991)
  • K863650 — QUANTIMAP III (September 26, 1986)

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