FDA.reportPublic FDA data

Samsung Electronics Co., Ltd.

Matched from indexed company URL: Samsung Electronics Co. Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103002123010300212Samsung Electronics Co., Ltd.1N2026-01-01129, Samsung-ro, Yeongtong-gu Suwon-si Gyeonggi KR 16677
30176163533017616353Samsung Electronics Co., Ltd. Mobile eXperience Business1N2026-01-01129, Samsung-ro, Yeongtong-gu Suwon-si Gyeonggi KR 16677
30321168903032116890SAMSUNG ELECTRONICS CO., LTD.1N2026-01-011077, Cheonho-daero, Gangdong-gu Seoul KR 05340

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3297121906881419K242651GM85IZL2024-10-01
1546891906881419K242651GM85IZL2024-10-01
3297121630338542K242478GF85 (models GF85-3P, GF85-SP)KPR2024-09-19
1546891630338542K242478GF85 (models GF85-3P, GF85-SP)KPR2024-09-19
2762401778199802K240909Samsung ECG App v 1.3 (ECG)QDA2024-08-02
2762401907417697K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationQDA2023-05-02
3297121468236769K222353GM85IZL2022-09-29
1546891468236769K222353GM85IZL2022-09-29
3297121765450527K220175GM85IZL2022-04-21
1546891765450527K220175GM85IZL2022-04-21
3297121674564649K201560Auto Lung Nodule DetectionMYN2021-08-31
1546891674564649K201560Auto Lung Nodule DetectionMYN2021-08-31
2762401487029952K201168ECG Monitor AppQDA2020-08-04
1546891565459604K182647GC70KPR2018-10-24
1546891923382047K182622GU60A, GU60A-65KPR2018-10-23
3297122071627563K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85AKPR2018-12-07
1546892071627563K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85AKPR2018-12-07
3297121067824995K181631GR40CWMQB2018-07-20
1546891067824995K181631GR40CWMQB2018-07-20
1546892058711707K181629GC85AKPR2018-07-20
3297122058711707K181629GC85AKPR2018-07-20
1546891783332630K181626Digital Diagnostic Mobile X-ray SystemIZL2018-07-20
3297121783332630K181626Digital Diagnostic Mobile X-ray SystemIZL2018-07-20
1546891616418472K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85KPR2018-05-24
3297121616418472K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85KPR2018-05-24
1546891239506234K173828GU60A & GU60A-65KPR2018-01-12
1546891006842596K172229GC85AKPR2017-11-22
3297121006842596K172229GC85AKPR2017-11-22
1546892043075914K171119GM85IZL2017-05-12
3297122043075914K171119GM85IZL2017-05-12
1546891761156130K163115GC70KPR2016-12-07
1546891749725160K162278Digital Diagnostic Mobile X-ray SystemIZL2016-11-15
3297121749725160K162278Digital Diagnostic Mobile X-ray SystemIZL2016-11-15
1546891492410685K160997GC85AKPR2016-07-06
3297121492410685K160997GC85AKPR2016-07-06
1546891861726307K153401GR40CWMQB2015-12-21
3297121861726307K153401GR40CWMQB2015-12-21
1546891328030606K152094GR40CWMQB2015-10-16
3297121328030606K152094GR40CWMQB2015-10-16
1546891636988254K151685GUA60A, GU60A-65KPR2015-07-17
1546891141341918K151419GF50AKPR2015-06-23
1546891913326976K150165GC85AKPR2015-04-02
3297121913326976K150165GC85AKPR2015-04-02
1546891017807564K150097GM60A-32S & GM60A-40SIZL2015-02-19
1546891790118035K143029Digital Diagnostic X-ray System (GC80)KPR2015-02-04
1546891535588688K142492GM60A-32S, GM60A-40SIZL2014-12-17
1546891928273842K140334XGEO GC80KPR2014-05-28
1546891918582760K140332XGEO GU60AKPR2014-05-28
1546891991203617K140326XGEO GF50KPR2014-05-29
3297121220008640K140235XGEO GR40CWMQB2014-05-15
1546891220008640K140235XGEO GR40CWMQB2014-05-15
1546891268237689K123106DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60AKPR2013-06-20
1546891460167917K123105XGEO GU60KPR2013-06-07
1546892006003992K123098XGEO GC80KPR2013-01-18
2762401853189541DEN230041Sleep Apnea FeatureQZW2024-02-06
1546891072462893

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPR332024-09-19
IZL172024-10-01
MQB122018-07-20
QDA32024-08-02
MYN22021-08-31
QZW12024-02-06

PMN#

GM85

2024-10-01

Samsung Electronics Co., Ltd.

GM85

2022-09-29

Samsung Electronics Co., LTD.

GM85

2022-04-21

Samsung Electronics Co. Ltd.

GEMS-H

2022-04-21

Samsung Electronics Co., Ltd.

GC70

2018-10-24

Samsung Electronics Co., Ltd.

GC85A

2018-07-20

Samsung Electronics Co., Ltd.

GR40CW

2018-07-20

Samsung Electronics Co., Ltd.

GC85A

2017-11-22

Samsung Electronics Co.,Ltd.

GM85

2017-05-12

Samsung Electronics Co.,Ltd.

GC70

2016-12-07

SAMSUNG ELECTRONICS CO., LTD.

GC85A

2016-07-06

SAMSUNG ELECTRONICS CO., LTD.

GR40CW

2015-12-21

SAMSUNG ELECTRONICS CO., LTD.

GR40CW

2015-10-16

SAMSUNG ELECTRONICS CO., LTD.

GF50A

2015-06-23

SAMSUNG ELECTRONICS CO., LTD.

GC85A

2015-04-02

SAMSUNG ELECTRONICS CO., LTD.

XGEO GF50

2014-05-29

SAMSUNG ELECTRONICS CO., LTD.

XGEO GC80

2014-05-28

SAMSUNG ELECTRONICS CO., LTD.

S HEALTH

2013-12-04

SAMSUNG ELECTRONICS CO., LTD.

XGEO GU60

2013-06-07

SAMSUNG ELECTRONICS CO., LTD.

XGEO GC80

2013-01-18

SAMSUNG ELECTRONICS CO., LTD.

GUDID#

Samsung ECG App v 1.3 (ECG) - The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN 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. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

Samsung Electronics Co., Ltd.

2025-06-10

Samsung ECG App v 1.3 (ECG) - The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN 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. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

Samsung Electronics Co., Ltd.

2025-06-10

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification - 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.

2023-10-23

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification - 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.

2023-10-23

NA - The Auto Lung Nodule Detection is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 10 to 30 mm in size. It is designed to aid the physician to review the PA chest radiographs of adults as a second reader and be used as part of S-Station, which is operation software installed on Samsung Digital X-ray Imaging systems. Auto Lung Nodule Detection cannot be used on the patients who have lung lesions other than abnormal nodules.

Samsung Electronics Co., Ltd.

2026-03-17

Samsung Sleep Apnea Feature (Android OS) - The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.

Samsung Electronics Co., Ltd.

2025-02-24

Samsung Sleep Apnea Feature (Wear OS) - The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders

Samsung Electronics Co., Ltd.

2025-02-24

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