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510(k) K884294

NICOLET NYSTAR PLUS SYSTEM by Nicolet Instrument Corp. — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1988
Date Received
October 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nystagmograph
Device Class
Class II
Regulation Number
882.1460
Review Panel
NE
Submission Type

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  • K894629 — NICOLET BEAM II SYSTEM (March 9, 1990)
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  • K883781 — NICOLET NEUROPORT/ACE SYSTEM (June 5, 1989)
  • K890495 — NICOLET VIKING II SYSTEM (March 16, 1989)

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