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510(k) K102610

FOCUS EMG DEVICE by Teleemg, LLC USA — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2011
Date Received
September 10, 2010
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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