FDA Registration
Active
🇺🇸 United States
EnSite X EP System EnSite Omnipolar Technology Data Export, ENSITE-OTEXPORT-01
Reg #: 3005334138
·
FEI: 3005334138
·
Expires 2025
Products
1
Proprietary Names
54
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- St. Jude Medical, Cardiology Division, Inc.
- Registration Number
- 3005334138
- FEI Number
- 3005334138
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5050 Nathan Lane North
- City
- Plymouth
- State
- MN
- ZIP
- 55442
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212061
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 | 2022-02-21 |
Proprietary Names
EnSite X EP System EnSite Omnipolar Technology Data Export, ENSITE-OTEXPORT-01
EnSite X EP System Display Workstation Cart, ENSITE-DWSCART-01
EnSite X EP System Field Frame, ENSITE-FF-01
EnSite X EP System Display Workstation, ENSITE-DWS-1.1
EnSite X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-01
EnSite X EP System ECG Output Module, ENSITE-ECGOUT-01
EnSite X EP System Connect Cable, ENSITE-ACBL-160-01
EnSite X EP System EnSite Omnipolar Technology Demo, ENSITE-D-OT-01
EnSite X EP System Wave Speed Map Demo, ENSITE-D-WS-01
EnSite X EP System Recording System IC Output Cable, ENSITE-CR-64-01
EnSite X EP System Display Workstation, ENSITE-R-DWS-01
EnSite X EP System Connect Cable, ENSITE-ACBL-60-01
EnSite X EP System Monitor Pole, ENSITE-MONPOLE-01
EnSite X EP System Surface Electrode Kit, ENSITE-SEK-5-01
EnSite X EP System Remote Monitor Stand, ENSITE-RMS-01
EnSite X EP System Amplifier, ENSITE-R-AMP-02
EnSite X EP System Display Workstation, ENSITE-DWS-01
EnSite Adjustable Field Frame Bracket, ENSITE-FF-ABRKT-01
EnSite X EP System Amplifier, ENSITE-R-AMP-01
EnSite Fixed Field Frame Bracket, ENSITE-FF-BRCKT-01
EnSite X EP System Triple Monitor Mount, ENSITE-TMMK-01
EnSite X EP System Amplifier Cart, ENSITE-AMPCART1-01
EnSite X EP System Field Frame Cable, ENSITE-FF-3MC-01
EnSite X EP System Field Frame Cable, ENSITE-FF-4.5C-01
EnSite X EP System IC Output Cable, ENSITE-WM64-60-01
EnSite X EP System ECG Cable, ENSITE-CECG-60-01
EnSite X EP System Recording System IC Output Cable, ENSITE-CR-56-01
EnSite X EP System Amplifier, ENSITE-AMP-01
EnSite X EP System EnSite Omnipolar Technology, ENSITE-OT-01
EnSite X EP System Contact Force Software License, ENSITE-CF-01
EnSite X EP System EnSite LiveView Dynamic Display, ENSITE-LV-01
EnSite X EP System Software Upgrade, ENSITE-SW-1.1
EnSite X EP System EnSite LiveView Dynamic Display Demo, ENSITE-D-LV-01
EnSite X EP System Dual Monitor Mount, ENSITE-DMMK-01
EnSite X EP System Catheter Input Module, ENSITE-CIM-80-01
EnSite X EP System IC Output Cable, ENSITE-WM64-144-01
EnSite X EP System Amplifier Cart, ENSITE-AMPCART3-01
EnSite X EP System Wave Speed Map, ENSITE-WS-01
EnSite X EP System ECG Cable, ENSITE-CECG-144-01
EnSite X EP System Bedrail Mount, ENSITE-RAILMNT-01
EnSite X EP System Contact Force Software License, ENSITE-D-CF-01
EnSite X EP System Display Workstation, ENSITE-R-DWS-1.1
EnSite X EP System Amplifier Power Module, ENSITE-AMP-EPM-01
EnSite X EP System Catheter Input Module, ENSITE-CIM-20-01
EnSite X EP System Radio-lucent ECG Lead Set, ENSITE-ECGRL-01
EnSite X EP System Live Export Software License, ENSITE-LE-01
EnSite X EP System Field Frame, ENSITE-R-FF-01
EnSite X EP System Single Monitor Mount, ENSITE-SMMK-01
EnSite X EP System IC Output Cable, ENSITE-WM56-60-01
EnSite X EP System Amplifier, ENSITE-AMP-02
EnSite X EP System SurfaceLink Module, ENSITE-SRFLNK-01
EnSite X EP System Patient Reference Sensor, ENSITE-PRSFRNT-01
EnSite X EP System Patient Reference Sensor, ENSITE-PRSBACK-01
EnSite X EP System IC Output Cable, ENSITE-WM56-144-01
Establishment Types
Complaint File Establishment per 21 CFR 820.198