KENTEC MEDICAL, INC.

Address:17871 FITCH,Irvine,CA,92614,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

System, Monitoring, Perinatal (HGM) (10)

Premarket Exempt

Yes No

Clear

Ameritus Transducer - 10817522010694 Catalog Number : ATG200-T

Device Description : transducer

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Ameritus Transducer - 10817522010700 Catalog Number : ATG200-U

Device Description : transducer

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Ameritus Transducer - 10817522010717 Catalog Number : ATG300-U

Device Description : transducer

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Ameritus Transducer - 10817522010724 Catalog Number : ATG303-TB

Device Description : transducer

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Ameritus Transducer - 10817522010731 Catalog Number : ATG400-U

Device Description : transducer

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Ameritus Transducer - 10817522010748 Catalog Number : ATG400-UB

Device Description : transducer

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Ameritus Transducer - 10817522010755 Catalog Number : ATG402-T

Device Description : transducer

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Ameritus Transducer - 10817522010762 Catalog Number : ATG402-TB

Device Description : transducer

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Ameritus Transducer - 10817522010779 Catalog Number : ATG-SLIM-TB

Device Description : transducer

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Ameritus Transducer - 10817522010786 Catalog Number : ATG-WAVE-T

Device Description : transducer

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

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