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FDA 510(k) Application Details - K092364
Device Classification Name
Magnet, Test, Pacemaker
More FDA Info for this Device
510(K) Number
K092364
Device Name
Magnet, Test, Pacemaker
Applicant
CYBERONICS, INC.
100 CYBERONICS BLVD.
HOUSTON, TX 77058-2017 US
Other 510(k) Applications for this Company
Contact
KAREN STUEBER
Other 510(k) Applications for this Contact
Regulation Number
870.3690
More FDA Info for this Regulation Number
Classification Product Code
DTG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/05/2009
Decision Date
11/03/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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