Esaote Europe B.V.

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) (9) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (9)

Premarket Exempt

No

Clear

MyLabSat USA - 08056304450043 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

SL1543 - 08056304450050 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

MyLabFive - 08056304450227 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

MyLabFive BASIC UNIT - 08056304450241 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

MyLab40 eHD - 08056304450388 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

MyLab40 - 08056304450395 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

MyLab20 Plus - 08056304450401 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

MyLab40 Basic Unit - 08056304450425 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

MyLabSix - 08056304450432 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

MyLabOne reg. Anestesia - 08056304450470 Catalog Number :

Device Class : 2

Duns Number: 404392797

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

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