CardioTek B.V.

Address:Dr. Nolenslaan 107B,GL SIttard Limburg,NL

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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

Computer, Diagnostic, Programmable (DQK) (5)

Premarket Exempt

Clear

Adapter cables unipolar/ bipolar (set of 10) - 04260441450482 Catalog Number :

Device Class : 2

Duns Number: 415868731

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

Aluminium carrying case - 04260441450574 Catalog Number :

Device Class : 2

Duns Number: 415868731

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

EP-TRACER - 04260441455326 Catalog Number :

Device Description : EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

Device Class : 2

Duns Number: 415868731

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

EP-TRACER - 04260441455418 Catalog Number :

Device Description : EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a co EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

Device Class : 2

Duns Number: 415868731

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

EP-TRACER - 04260441455425 Catalog Number :

Device Description : EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a co EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

Device Class : 2

Duns Number: 415868731

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

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