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FDA 510(k) Application Details - K071185
Device Classification Name
Electrode, Needle
More FDA Info for this Device
510(K) Number
K071185
Device Name
Electrode, Needle
Applicant
AMBU A/S
6740 BAYMEADOW DR.
GLEN BURNIE, MD 21060 US
Other 510(k) Applications for this Company
Contact
SANJAY PARIKH
Other 510(k) Applications for this Contact
Regulation Number
882.1350
More FDA Info for this Regulation Number
Classification Product Code
GXZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/30/2007
Decision Date
05/30/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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