FUJIFILM SONOSITE, INC.

Address:21919 30th Dr SE,BOTHELL,WA,98021,US

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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) (6) System, imaging, pulsed echo, ultrasonic (IYO) (6)

Premarket Exempt

Clear

SonoSite Edge - 00841517100230 Catalog Number :

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

SonoSite Edge - 00841517100247 Catalog Number :

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

SonoSite M-Turbo - 00841517100254 Catalog Number :

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

SonoSite M-Turbo - 00841517100261 Catalog Number :

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

SonoSite S-Series - 00841517100278 Catalog Number :

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

SonoSite S-Series - 00841517100285 Catalog Number :

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

C11x/8-5 MHz - 00841517100292 Catalog Number :

Device Description : Diagnostic Ultrasound Transducer

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

C60x/5-2 MHz - 00841517100308 Catalog Number : P07680

Device Description : Diagnostic Ultrasound Transducer

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

C60x/5-2 MHz - 00841517100315 Catalog Number : P07680

Device Description : Diagnostic Ultrasound Transducer

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

HFL38x/13-6 MHz - 00841517100322 Catalog Number :

Device Description : Diagnostic Ultrasound Transducer

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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