Avante

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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

Monitor, Blood-Flow, Ultrasonic (HEP) (6) Monitor, Ultrasonic, Fetal (KNG) (6) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (3) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (1) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

No Yes

Clear

Crystal 4P - 00815871020329 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

DM-530 - 00815871020336 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : BTA

Prescription Use : No

Device Count : 1

DM-660 - 00815871020343 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : BTA

Prescription Use : No

Device Count : 1

DM-660 - 00815871020350 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : BTA

Prescription Use : No

Device Count : 1

E-ST - 00815871020367 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HEP, KNG

Prescription Use : No

Device Count : 1

E-ST - 00815871020374 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : KNG, HEP

Prescription Use : No

Device Count : 1

E-ST - 00815871020381 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : KNG, HEP

Prescription Use : No

Device Count : 1

E-ST - 00815871020398 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HEP, KNG

Prescription Use : No

Device Count : 1

E-ST - 00815871020404 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HEP, KNG

Prescription Use : No

Device Count : 1

E-ST - 00815871020411 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HEP, KNG

Prescription Use : No

Device Count : 1

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