COAPT LLC

COAPT LLC

Address:303 W. Institute Pl.,Chicago,IL,60610,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

Electrode, Cutaneous (GXY) (7) Device, Prosthesis Alignment (IQO) (1)

Premarket Exempt

No Yes

Clear

Complete Controller - B618A0 Catalog Number : CC110

Device Description : Pattern Recognition Processing Unit

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Complete Communicator - B618B0 Catalog Number :

Device Description : PC-Side Wireless Radio Receiver Unit

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Complete Co-Amp - B618C0 Catalog Number :

Device Description : 8-Channel EMG Front End Processing Unit

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Complete Calibrate - B618D0 Catalog Number :

Device Description : Socket-Mount Calibration Unit

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Dome Electrodes - B618E0 Catalog Number :

Device Description : Non-invasive, cutaneous electrode for use with recording and monitoring equipmen

Device Class :

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 18

COMPLETE CONTROL System Gen2 - B618N1 Catalog Number :

Device Description : The COMPLETE CONTROL System Gen2 is an advanced control solution designed to pro

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Gen2 System Kit - B618P1 Catalog Number :

Device Description : The Gen2 System Kit is a medical device kit that contains the Coapt COMPLETE CON

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Coapt Evaluation Kit - B618Q1 Catalog Number :

Device Description : The Coapt Evaluation Kit is a handheld clinical tool created with technology fro

Device Class : 1

Duns Number: 078505297

Premarket Exempt : Yes

Product Code : IQO

Prescription Use : No

Device Count : 1

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