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FDA 510(k) Applications Submitted by ESAOTE EUROPE B.V.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K141486
06/05/2014
MYLABSIX ULTRASOUND SYSTEM
ESAOTE EUROPE B.V.
K101605
06/08/2010
MYLABONE ULTRASOUND SYSTEM
ESAOTE EUROPE B.V.
K161168
04/26/2016
MyLabSix Ultrasound System
Esaote Europe B.V.
K070903
04/02/2007
MYLAB40
ESAOTE EUROPE B.V.
K061755
06/21/2006
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM
ESAOTE EUROPE B.V.
K062598
09/01/2006
IMT.LAB SOFTWARE
ESAOTE EUROPE B.V.
K083882
12/29/2008
MYLABFIVE
ESAOTE EUROPE B.V.
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