IMACOR INC

Address:50 Jericho Turnpike,Jericho,NY,11753,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, Imaging, Pulsed Echo, Ultrasonic (IYO) (2) Transducer, Ultrasonic, Diagnostic (ITX) (2) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (1)

Premarket Exempt

No Yes

Clear

ClariTEE - 00861589000108 Catalog Number : CLT-010

Device Description : TEE ultrasound probe, single use, EO Sterile

Device Class :

Duns Number: 604116553

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

ImaCor Inc. - 00861589000115 Catalog Number :

Device Description : Ultrasound Machine for use with ClariTEE probe

Device Class : 2

Duns Number: 604116553

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

ImaCor - 00861589000139 Catalog Number :

Device Class : 2

Duns Number: 604116553

Premarket Exempt : Yes

Product Code : IYN, ITX, IYO

Prescription Use : No

Device Count : 1

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