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The Eversense NOW Remote Monitoring App is intended for home use. The mobile app is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information. The secondary display is not a replacement for either real time continuous glucose monitoring using the Eversense CGM System’s primary display, or for home blood glucose monitoring. The Eversense NOW Remote Monitoring App is not intended to be used to make treatment decisions or therapy adjustments.
SENSEONICS, INCORPORATED
FG-5902-01-300
In Commercial Distribution
- 00817491023490 ()
FG-5902-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution
- 00817491022387 ()
FG-5502-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution
- 00817491022370 ()
FG-5501-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5600-01-300
Not in Commercial Distribution
- 00817491020826 ()
FG-5600-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5500-01-300
Not in Commercial Distribution
- 00817491020819 ()
FG-5500-01-300
- Implantable glucose monitoring system
No Description
BIOTRONIK SE & Co. KG
493241
In Commercial Distribution
- 04035479188733 ()
493241
- Implantable electrical stimulation device management software
No Description
BIOTRONIK SE & Co. KG
487878
In Commercial Distribution
- 04035479185817 ()
487878
- Implantable electrical stimulation device management software
For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a home environment, the content of the SPM01K4 convenience kit is:
1 electrostimulator SPM01M1 configuration;
electrodes;
protective skin, and
1 tablet with the MySPM@Home mobile application (SPM01A2).
NCS LAB SRL
SPM01K4
In Commercial Distribution
- 08051122040971 ()
SPM01K4
- Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
267363
In Commercial Distribution
- 03661489673634 ()
- Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
NXSTAGE MEDICAL, INC.
NX1379
Not in Commercial Distribution
- M535NX1225NX1379 ()
- Medical equipment clinical data interfacing software