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510(k) K063447

INSIGHT DISCOVERY by Fasstech — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2007
Date Received
November 15, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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