TERATECH CORPORATION

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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, Imaging, Pulsed Doppler, Ultrasonic (IYN) (4) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (3) Transducer, Ultrasonic, Diagnostic (ITX) (3)

Premarket Exempt

Clear

Terason - 00852698007300 Catalog Number :

Device Description : AC/DC Medical Grade Power Adapter with AC Cord

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYO, IYN

Prescription Use : Yes

Device Count : 1

Terason - 00852698007386 Catalog Number :

Device Description : Triple Programmable USB Foot Switch with Freeze, Save, Store Functions

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYN

Prescription Use : Yes

Device Count : 1

Terason - 00852698007409 Catalog Number :

Device Description : The Terason 8BP4 is an endocavity ultrasound transducer. Bi-planar: Curve and Li The Terason 8BP4 is an endocavity ultrasound transducer. Bi-planar: Curve and Linear array with a trans-rectal application.

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Terason - 00852698007416 Catalog Number :

Device Description : The Terason uSmart3200T Cart is used to provide a portable solution-On-Wheels fo The Terason uSmart3200T Cart is used to provide a portable solution-On-Wheels for the Terason uSmart3200T Ultrasound Imaging System.

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Terason - 00852698007508 Catalog Number :

Device Description : Terason uSmart3200T PLUS ultrasound system

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

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