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510(k) K923315

NICOLET ARK SYSTEM by Nicolet Instrument Corp. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1992
Date Received
July 7, 1992
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

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  • K894629 — NICOLET BEAM II SYSTEM (March 9, 1990)
  • K896477 — NICOLET REAL EAR ANALYZER (February 8, 1990)
  • K883781 — NICOLET NEUROPORT/ACE SYSTEM (June 5, 1989)
  • K890495 — NICOLET VIKING II SYSTEM (March 16, 1989)
  • K884294 — NICOLET NYSTAR PLUS SYSTEM (November 23, 1988)

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