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FDA 510(k) Application Details - K073593
Device Classification Name
Probe, Blood-Flow, Extravascular
More FDA Info for this Device
510(K) Number
K073593
Device Name
Probe, Blood-Flow, Extravascular
Applicant
DELTEX MEDICAL LIMITED
BUSINESS & TECHNOLOGY CENTER/
BESSEMER DRIVE
STEVENAGE, HERTFORDSHIRE SG1 2DX GB
Other 510(k) Applications for this Company
Contact
NEIL R ARMSTRONG
Other 510(k) Applications for this Contact
Regulation Number
870.2120
More FDA Info for this Regulation Number
Classification Product Code
DPT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/21/2007
Decision Date
01/29/2009
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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