WorkMate Scribe Module, Software Upgrade Kit

Registration Details

Registration Name: St. Jude Medical
Registration Number: 3012179728
FEI Number: 3012179728
Status: Active
Expiry Year: 2025
Initial Importer: Yes
Address: 2305 Walnut Street
City: Roseville
State: MN
ZIP: 55113
Country: US

Regulatory Submissions

510(k) Number: K210392

Owner / Operator

Firm Name: ABBOTT LABORATORIES
Operator Number: 1415939
Address: 100 ABBOTT PARK RD., D-03Q3, AP52-1
City: Abbott Park
State: IL
Postal Code: 60064
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Computer, Diagnostic, Programmable	DQK	Class 2	Cardiovascular	No	2022-11-02

Proprietary Names

WorkMate Scribe Module, Software Upgrade Kit WorkMate Claris System, Display Plus Amplifier Cable Assy, IBP, Omedha DTXX Catheter Input Module 1-56 EP-WorkMate/EP-4 USB Keyboard WorkMate Scribe Module 110V with Physio Catheter Input Module 57-120 WM Claris Z440 v.1.2 Upgrade Kit Cable Assy, IBP, Namic Preceptors DT WorkMate Scribe Module WorkMate Claris OS Patch SW Kit WorkMate Unity DICOM Module Fiber Optic Cable - Duplex LC/LC Power Supply Connector Adapter LCD Dual Monitor Mount Kit Reverse IEC Accessory Power Strip Cable Assy, IBP, Baxter Truwave WorkMate ImageSync Module incorrect Power Cord, C-18 to C-7, 250V SCU II Assembly 448 Channel EP-4 Stimulator System 110V Cable Assy, IBP, Merit Meritrans WorkMate Unity HL7 Module SCU II Assembly 96 Channel Cable Assy, IBP, Medex 860 WM Scribe Onyx v.1.2 Upgrade Kit v.1.2.1 Onyx Scribe Upgrade Kit 4 Outlet Reverse IEC Accessory Power Str Cable Assy, IBP, Utah Deltran Cable Assy, IBP, Medex 950 Fiber Optic Cable - Duplex LC/LC 30m WM Claris Additional Monitor Cable Kit Monitor, Touch Screen LCD, 19 Inch Media Conv, SC Fiber to DB9 USB Keyboard, Wired, English Cable Assy, IBP, Abbott Transpac IV DVI to DisplayPort Adapter WorkMate Claris System, ECG Cable Set, Radiolucent EP-4 Cardiac Stimulator DMS59 to Dual DVI SPlitter Video Cable Cable, COAX v.1.2.1 Z620 Upgrade Kit WorkMate Claris Bed Rail Kit WorkMate Claris PM Kit DWG 90169898 WM Claris Z620 v.1.2 Upgrade Kit Ferrite, Round Cable Snap-its, 200MHz-10 Cable Equipotential Kit WM Claris V1.1 Upgrade WorkMate Claris System, Cable Kit WorkMate Claris System, ECG Cable Set, Radiopaque Radiotranslucent Leadwire WorkMate Claris System, Bed Rail Kit WorkMate Claris System, Bed Bracket Assembly WorkMate Scribe CPU WM Unity Review Mod - Sgl User License Cable, Serial, 3 ft DB9 Power Supply, 5V MG with 2.5MM I.D. USB Optical Scroll Mouse, Wired v.1.2.1 Z440 Upgrade Kit WM Unity Review Module - Site License Monitor, LCD, 16:9 1920x1080 Resolution WorkMate Claris System, Grounding Cable WorkMate Claris System, System - Display Plus WorkMate Claris System, ECG Cable DVI to HDMI Adapter EP-4 Touch Screen Computer Additional Monitor Stand Kit WM Unity Review Module - 10 User License Cable Assy, Stim, EP4 S-Video to VGA Signal Converter Power Conditioner, 120 VAC, 1440 VA Medi Cable Assy, IBP, Medex 960 Media Conv, DB9 to Fiber SC Ferrite round cable snap its 1 to 300MHz Stim Cable, WorkMate Claris Generic WM Claris Power Kit, 110 Power Conditioner, 120 VAC, 600 VA, Keyboard, PS2, Wired 2-port DVI splitter WorkMate Scribe Module, Display Workstation Kit ECG Cable Radio-Translucent 36in Brn Mouse, PS2, Wired WM Claris CPU Cable Assy, IBP, Maxxim Cobe WorkMate Claris System, Bottom Shelf Computer Bench WorkMate Claris System, CI Module 1 WorkMate Claris System, Invasive Blood Pressure Cable WorkMate Claris System, Software Upgrade Kit WorkMate Claris System, Generic Stimulator Cable WorkMate Claris System, Printer WorkMate Claris System, Preventative Maintenance Kit WorkMate Claris System, Bracket Bottom Shelf Computer Bench WorkMate Claris System Display Workstation EP-4 Cardiac Stimulator, Cardiac Stimulator Cable WorkMate Claris System, CI Module 2 WorkMate Claris System WorkMate Claris System, Module Cart WorkMate Claris System, Cart WorkMate Claris System, Amplifier

Establishment Types

Manufacture Medical Device