28 results
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65ms
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Sources: EU EUDAMED, US FDA
Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging
FDA 510(k)
FDA Class 2
·Radiology
Diagnostic Ultrasound Imaging System
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Leltek Inc.·1 device
Diagnostic Ultrasound Imaging System
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Leltek Inc.·1 device
Diagnostic Ultrasound Imaging System
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Leltek Inc.·1 device
Diagnostic Ultrasound Imaging System
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·Leltek Inc.·1 device
FI20/00010
Certificate
MDD Annex II (excluding section 4)·Leltek Inc.·DNV Product Assurance AS·2 Basic UDI-DIs
FI2000010
Certificate
MDD Annex II Section 4·Leltek Inc.·SGS FIMKO OY·1 Basic UDI-DI
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices