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FDA 510(k) Application Details - K071697
Device Classification Name
Electrode, Depth
More FDA Info for this Device
510(K) Number
K071697
Device Name
Electrode, Depth
Applicant
ALPHA OMEGA LTD.
HA'AVODA ST., P.O. BOX 810
NAZARETH ILLIT 17105 IL
Other 510(k) Applications for this Company
Contact
BAHEEJ DANIAL
Other 510(k) Applications for this Contact
Regulation Number
882.1330
More FDA Info for this Regulation Number
Classification Product Code
GZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/20/2007
Decision Date
12/03/2007
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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