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510(k) K883781

NICOLET NEUROPORT/ACE SYSTEM by Nicolet Instrument Corp. — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1989
Date Received
September 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type

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  • K890495 — NICOLET VIKING II SYSTEM (March 16, 1989)
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