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510(k) K083577

HARMONIE SYSTEM by Stellate Systems — Product Code GWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2011
Date Received
December 3, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Other clearances by Stellate Systems

  • K013450 — NOTTA AMBULATORY RECORDER (January 14, 2002)
  • K010728 — HARMONE-SCHWARZER EEG SYSTEM (May 21, 2001)
  • K982351 — LUNA (July 29, 1998)
  • K955577 — ECLIPSE VERSION 3.0 (September 20, 1996)
  • K960273 — HARMONIE SENSA (April 4, 1996)
  • K912938 — RHYTHM (July 30, 1991)

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