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510(k) K071186

MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE by Ambu A/S — Product Code IKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2007
Date Received
April 30, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type

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