ABBOTT

Address:605 Tri-State Parkway,Gurnee,IL,60031,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) (2) CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY (MTD) (1) Electrode, electrocardiograph (DRX) (1)

Premarket Exempt

No Yes

Clear

RhythmView - 00810591020161 Catalog Number : 2000-R

Device Description : RhythmView Workstation, US, refurbished

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

RhythmView - 00810591020185 Catalog Number : 2002-R

Device Description : RhythmView Workstation, US, streaming, refurbished

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

RhythmView - 00810591020208 Catalog Number : RVP4735

Device Description : RhythmView Reference Electrode

Device Class : 2

Duns Number: 080174723

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

FIRMap - 00810591020246 Catalog Number : FOC002NS

Device Description : FIRMap Catheter Fan Out Cable (2m) - Abbott (Global), Non-Sterile

Device Class : 2

Duns Number: 080174723

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

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