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FDA 510(k) Application Details - K002137
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K002137
Device Name
Computer, Diagnostic, Programmable
Applicant
SIEMENS ELEMA AB
ELECTROMEDICAL SYSTEMS GROUP
16 ELECTRONICS AVENUE
DANVERS, MA 01923 US
Other 510(k) Applications for this Company
Contact
DAVE SIMARD
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/14/2000
Decision Date
10/05/2000
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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