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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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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