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FDA 510(k) Application Details - K101345
Device Classification Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
More FDA Info for this Device
510(K) Number
K101345
Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR, CA 91765 US
Other 510(k) Applications for this Company
Contact
Balaka Das
Other 510(k) Applications for this Contact
Regulation Number
870.1220
More FDA Info for this Regulation Number
Classification Product Code
DRF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/13/2010
Decision Date
06/22/2010
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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