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FDA 510(k) Application Details - K944314
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K944314
Device Name
Electrode, Cutaneous
Applicant
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN, IL 60060-3700 US
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Contact
RON ROLFSEN
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/29/1994
Decision Date
01/03/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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