FDA 510(k) Application Details - K123216

Device Classification Name Probe, Blood-Flow, Extravascular

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510(K) Number K123216
Device Name Probe, Blood-Flow, Extravascular
Applicant AIMAGO SA
Parc Scientifique EPFL 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 10/15/2012
Decision Date 02/07/2013
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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