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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K123216
Device Name AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN
Applicant
Aimago SA
Parc Scientifique Epfl D
4th Floor
Lausanne,  CH 1015
Applicant Contact MARC ANDRE
Correspondent
Aimago SA
Parc Scientifique Epfl D
4th Floor
Lausanne,  CH 1015
Correspondent Contact MARC ANDRE
Regulation Number870.2120
Classification Product Code
DPT  
Date Received10/15/2012
Decision Date 02/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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