Medical Device Manufacturer · US , Carmel , IN

Esaote Europe B.V. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2006
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Esaote Europe B.V. Radiology ✕
7 devices
1-7 of 7
Cleared Sep 02, 2016
MyLabSix Ultrasound System
K161168 · IYN
Radiology · 129d
Cleared Jul 11, 2014
MYLABSIX ULTRASOUND SYSTEM
K141486 · IYN
Radiology · 36d
Cleared Aug 31, 2010
MYLABONE ULTRASOUND SYSTEM
K101605 · IYN
Radiology · 84d
Cleared Jan 30, 2009
MYLABFIVE
K083882 · IYN
Radiology · 32d
Cleared Jul 02, 2007
MYLAB40
K070903 · ITX
Radiology · 91d
Cleared Oct 31, 2006
IMT.LAB SOFTWARE
K062598 · LLZ
Radiology · 60d
Cleared Aug 07, 2006
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM
K061755 · IYO
Radiology · 47d
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