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The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094940756 ()
- Self-care monitoring/reporting software
Samsung Health Body Composition tracker for android OS smart watch
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution
- 08806092938854 ()
- Bioelectrical body composition analyser
Samsung Health Body Composition tracker for android OS smart phone
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution
- 08806092938847 ()
- Bioelectrical body composition analyser
No Description
Luxsonic Technologies, Inc
1.x
In Commercial Distribution
- G554LVIC0 ()
- Radiology DICOM image processing application software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution
- 00842318117212 ()
- Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution
- 00842318117205 ()
- Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution
- 00842318117199 ()
- Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution
- 00842318117182 ()
- Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution
- 00842318117175 ()
- Audiometric/hearing device software
Sunquest Transfusion Manager is blood bank information system application software
CliniSys, Inc
2.x
Not in Commercial Distribution
- B236TRM0 ()
- Blood bank information system application software
Sunquest Blood Bank System
CliniSys, Inc
8.3.x
Not in Commercial Distribution
- B236LABBB830 ()
- Blood bank information system application software
Sunquest Blood Bank System
CliniSys, Inc
8.x
Not in Commercial Distribution
- B236LABBB0 ()
- Blood bank information system application software
NEOLUX X 350-48
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution
- B280864NL4800X0 ()
864NL4800X
- Ultraviolet phototherapy unit, professional
NEOLUX X 350-40
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution
- B280864NL4000X0 ()
864NL4000X
- Ultraviolet phototherapy unit, professional
NEOLUX X 311/350-24/24
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution
- B280864NL2424X0 ()
864NL2424X
- Ultraviolet phototherapy unit, professional
NEOLUX X 311/350-20/20
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution
- B280864NL2020X0 ()
864NL2020X
- Ultraviolet phototherapy unit, professional
NEOLUX X 311-48
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution
- B280864NL0048X0 ()
864NL0048X
- Ultraviolet phototherapy unit, professional
NEOLUX X 311-40
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution
- B280864NL0040X0 ()
864NL0040X
- Ultraviolet phototherapy unit, professional
CapSure Cloud is a secure cloud-based web application for medical image archiving and management.
Globalmed Holdings, LLC
2.1.x
Not in Commercial Distribution
- B377GMR1602008X0 ()
- Multidisciplinary medical image management software
No Description
H & O Equipments SA
CryoProbe|x
In Commercial Distribution
- B386SHOCXPRXX8010 ()
S-HO-CXPR-XX-801
- General cryosurgical system, cryogen gas, mechanical