KOVEN TECHNOLOGY, INC.

Address:477 N Lindbergh Blvd,Saint Louis,MO,63141,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 (JOP) (6) Monitor, Ultrasonic, Nonfetal (JAF) (4) Transducer, Ultrasonic, Diagnostic (ITX) (4)

Premarket Exempt

No Yes

Clear

Pencil probe - 00894912002418 Catalog Number : P8M05S8A

Device Description : Reusable CW Doppler pencil probe, 8 MHz

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

T10M5S8C - 00894912002425 Catalog Number : T10M5S8C

Device Description : 10 MHz curly cable clinic CW Doppler probe.

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

T2M20S8C - 00894912002432 Catalog Number : T2M20S8C

Device Description : 2 MHz CW Doppler probe.

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

T5M05S8C - 00894912002449 Catalog Number : T5M05S8C

Device Description : 5 MHz curly cable clinic CW Doppler probe.

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

T8M05S8C - 00894912002456 Catalog Number : T8M05S8C

Device Description : 8 MHz curly cable clinic CW Doppler probe.

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

T2M25N8A - 00894912002463 Catalog Number : T2M25N8A

Device Description : 2 MHz Fetal Doppler probe for the ES102EX fetal Doppler.

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

ACP-08 - 00894912002494 Catalog Number : ACP-08

Device Description : PW Doppler probe, 8 MHz

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : ITX, JAF

Prescription Use : Yes

Device Count : 1

CRP Probe - 00894912002500 Catalog Number : CRP-10H

Device Description : PW Cardiovascular Doppler probe, 10 MHz

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : JAF, ITX

Prescription Use : Yes

Device Count : 1

CRP Probe - 00894912002517 Catalog Number : CRP-20H

Device Description : PW Cardiovascular Doppler probe, 20 MHz

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : JAF, ITX

Prescription Use : Yes

Device Count : 1

CRP Probe - 00894912002524 Catalog Number : CRP-20H1N

Device Description : 1.2mm tip PW cardiovascular Doppler probe, 20 MHz

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : JAF, ITX

Prescription Use : Yes

Device Count : 1

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