Declarations of Conformity | Abbott Cardiovascular
CARDIOVASCULAR
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DECLARATIONS OF CONFORMITY (DOC) FOR EUROPEAN UNION RADIO EQUIPMENT DIRECTIVE (RED)

The following Abbott product(s) conform to the applicable provisions of the Radio Equipment Directive (2014/53/EU). All supporting documentation is retained under the premises of Abbott. This declaration is issued under the sole responsibility of the manufacturer. This declaration supersedes any declaration issued previously for the same product(s).

Each document may contain the following translations: English, Bulgarian, Croatian, Czech, Danish, Dutch, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish and Turkish.

CRM: IMPLANTABLE PACEMAKERS AND CRT-P DEVICES

Accent™, Accent MRI™
Allure™, Allure Quadra™
Anthem™
Assurity™, Assurity MRI™
Quadra Allure™

Accent™, Accent MRI™
Allure™, Allure Quadra™
Anthem™
Endurity™, Endurity™ Core, Endurity MRI™
Sustain™
Verity™
Zephyr™

CRM: IMPLANTABLE ICD AND CRT-D DEVICES

Ellipse™
Fortify™, Fortify Assura™
Quadra Assura™
Unify™, Unify Quadra™, Unify Assura™

CRM: IMPLANTABLE CARDIAC MONITORS
CARDIOMEMS™ HF SYSTEM

CardioMEMS™ hospital electronics system
CardioMEMS™ i3 patient electronics system
CardioMEMS™ PA sensor and delivery catheter

MAPPING AND VISUALIZATION

EnSite™ Velocity™ cardiac mapping system
EnSite Precision™ Module, Sensor Enabled™

VASCULAR

PressureWire™ Aeris with Agile Tip,
PressureWire™ X Wireless Connection

Wi-Box™ AO Transmitter
AO USB Receiver
PW USB Receiver

ILUMIEN™ OPTIS™ system
OPTIS™ Integrated System
OPTIS™ Mobile System

SJM-CV WEB-0818-0132a

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