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

System, Monitoring, Perinatal (HGM) (8) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (2) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (2) Transducer, Ultrasonic, Diagnostic (ITX) (2) Transducer, Ultrasonic, Obstetric (HGL) (1)

Premarket Exempt

No Yes

Clear

Compact FM - 00815871020220 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Compact Plus - 00815871020237 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Compact Plus - 00815871020244 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Compact Plus - 00815871020251 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Compact Plus - 00815871020268 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Compact Plus - 00815871020275 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Compact Plus - 00815871020282 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Compact II - 00815871020299 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HGL, HGM

Prescription Use : No

Device Count : 1

Crystal 4P - 00815871020305 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : No

Device Count : 1

Crystal 4P - 00815871020312 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

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