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FDA 510(k) Application Details - K062478
Device Classification Name
Stimulator, Nerve, Battery-Powered
More FDA Info for this Device
510(K) Number
K062478
Device Name
Stimulator, Nerve, Battery-Powered
Applicant
MEDTRONIC A/S
16-18 TONSBAKKEN
SKOVLUNDE DK-2740 DK
Other 510(k) Applications for this Company
Contact
ANN-CHRISTINE PROVOOST
Other 510(k) Applications for this Contact
Regulation Number
868.2775
More FDA Info for this Regulation Number
Classification Product Code
BXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/24/2006
Decision Date
02/08/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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