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FDA 510(k) Application Details - K142969
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K142969
Device Name
Electrocardiograph
Applicant
MDOLORIS MEDICAL SYSTEMS SAS
6, RUE DU PR LAGUESSE
LILLE 59037 FR
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Contact
MATHILDE COLLET
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/14/2014
Decision Date
02/23/2016
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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