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FDA 510(k) Application Details - K073415
Device Classification Name
Electromyograph, Diagnostic
More FDA Info for this Device
510(K) Number
K073415
Device Name
Electromyograph, Diagnostic
Applicant
EB NEURO, S.P.A.
11460 N. MERIDIAN ST.
SUITE 150
CARMEL, IN 46032 US
Other 510(k) Applications for this Company
Contact
Allison Scott
Other 510(k) Applications for this Contact
Regulation Number
890.1375
More FDA Info for this Regulation Number
Classification Product Code
IKN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/04/2007
Decision Date
05/23/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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