SW D00U027 SS LINQ II PLATFORM APP

SW D00U027 SS LINQ II PLATFORM APP
CareLink SmartSync™ LINQ II™ Platform Application - D00U027

An application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MXD

Device Name: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 870.1025

Third Party Flag: N

Medical Specialty: CV

Device Id: 00763000891091

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A