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FDA 510(k) Application Details - K121429
Device Classification Name
Probe, Blood-Flow, Extravascular
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510(K) Number
K121429
Device Name
Probe, Blood-Flow, Extravascular
Applicant
AIMAGO SA
PARC SCIENTIFIQUE EPFL,
PSE-D, 4TH FLOOR
LAUSANNE 1015 CH
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Contact
MARC ANDRE
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Regulation Number
870.2120
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Classification Product Code
DPT
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More FDA Info for this Product Code
Date Received
05/14/2012
Decision Date
08/10/2012
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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