ACUTUS MEDICAL, INC.

Address:2210 Faraday Ave Ste 100,Carlsbad,CA,92008,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

Computer, Diagnostic, Programmable (DQK) (10)

Premarket Exempt

No Yes

Clear

AcQMap - 00857042007234 Catalog Number : 800424

Device Description : AcQMap ECG Output Cable

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007241 Catalog Number : 800421

Device Description : AcQMap ECG Input Cable

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007258 Catalog Number : 800524

Device Description : AcQMap ECG POST Cable

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007265 Catalog Number : 800522

Device Description : AcQMap ECG w/Snaps Cable

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007272 Catalog Number : 800523

Device Description : AcQMap 2mm Pin Jumper St

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007289 Catalog Number : 800520

Device Description : AcQMap Workstation

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007296 Catalog Number : 800500

Device Description : AcQMap Console

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007302 Catalog Number : 800422

Device Description : AcQMap Auxiliary Interface Box

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007319 Catalog Number : 800508

Device Description : AcQMap Ablation Electrogram Cable

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007326 Catalog Number : 800505

Device Description : AcQMap Ablation Reference Cable

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

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