Esaote Europe B.V.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Transducer, Ultrasonic, Diagnostic (ITX) (10) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (2) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (2)

Premarket Exempt

Clear

SE3123 - 08056304451743 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

CA1123 - 08056304451750 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SC3121 - 08056304451767 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

LA533 - 08056304451774 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SL3332 - 08056304451781 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SP3630 - 08056304451798 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SL3413 - 08056304451804 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SB3123 - 08056304451835 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

MyLabOne BASIC UNIT - 08056304453006 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

MyLabOne - 08056304453013 Catalog Number :

Device Description : Soft. Version R20

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

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