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510(k) K855232

SOMATOSENSORY EVOKED POTENTIAL STIMULATOR by Neuroscience, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1986
Date Received
December 30, 1985
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 Neuroscience, Inc.

  • K871931 — ISTAT SOFTWARE (October 13, 1987)
  • K870263 — NEUROMAPPER 1620 (April 10, 1987)
  • K850430 — NEUROSCIENCE MAP-10 EEG (July 17, 1985)

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