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510(k) K861900

LIFESCAN EVOKED POTENTIAL SYSTEM by Neurometrics — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1986
Date Received
May 16, 1986
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 Neurometrics

  • K841790 — LIFESCAN EEG MONITOR (July 12, 1984)
  • K800452 — NEUROMETRICS MONITOR (April 2, 1980)

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