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FDA 510(k) Application Details - K061905
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K061905
Device Name
Computer, Diagnostic, Programmable
Applicant
MEDCON LTD.
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
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Contact
JONATHAN S KAHAN
Other 510(k) Applications for this Contact
Regulation Number
870.1425
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Classification Product Code
DQK
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More FDA Info for this Product Code
Date Received
07/05/2006
Decision Date
11/08/2006
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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