KOVEN TECHNOLOGY, INC.

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

Cart, Emergency, Cardiopulmonary (Excluding Equipment) (BZN) (4) Flowmeter, Blood, Cardiovascular (DPW) (3) Transducer, Ultrasonic (JOP) (3) Monitor, Ultrasonic, Fetal (KNG) (1)

Premarket Exempt

No Yes

Clear

CT - 00894912002005 Catalog Number : CT-1

Device Description : Doppler roll cart

Device Class : 1

Duns Number: 069261402

Premarket Exempt : Yes

Product Code : BZN

Prescription Use : No

Device Count : 1

CT - 00894912002012 Catalog Number : CT-2

Device Description : Doppler roll cart

Device Class : 1

Duns Number: 069261402

Premarket Exempt : Yes

Product Code : BZN

Prescription Use : No

Device Count : 1

ES100X MiniDop - 00894912002029 Catalog Number : ES100X

Device Description : Handheld Doppler

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

CT - 00894912002036 Catalog Number : CT-4

Device Description : Doppler roll cart

Device Class : 1

Duns Number: 069261402

Premarket Exempt : Yes

Product Code : BZN

Prescription Use : No

Device Count : 1

BiDop 3 - 00894912002043 Catalog Number : ES-100V3

Device Description : Bidirectional Doppler with waveform display.

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : DPW, JOP

Prescription Use : Yes

Device Count : 1

ES100VX - 00894912002050 Catalog Number : ES100VX

Device Description : Handheld Doppler

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : DPW

Prescription Use : Yes

Device Count : 1

ES101EX - 00894912002074 Catalog Number : ES101EX-2

Device Description : Fetal Echosounder Doppler.

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : KNG

Prescription Use : Yes

Device Count : 1

CT - 00894912002081 Catalog Number : CT-6

Device Description : Doppler roll cart

Device Class : 1

Duns Number: 069261402

Premarket Exempt : Yes

Product Code : BZN

Prescription Use : No

Device Count : 1

Smartdop 30EX - 00894912002098 Catalog Number : Smartdop 30EX

Device Description : Bidirectional recording Doppler with automatic cuff inflator.

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : DPW

Prescription Use : Yes

Device Count : 1

HD-307 - 00894912002104 Catalog Number : HD-307-8

Device Description : Bidirectional Doppler, 8 MHz

Device Class : 2

Duns Number: 069261402

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

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