Data / Medical devices / South Korea / Samsung Electronics Co., Ltd. Mobile eXperience Business
Samsung Electronics Co., Ltd. Mobile eXperience Business: FDA-registered device maker in Suwon-si Gyeonggi, South Korea, 6 510(k) clearances
Samsung Electronics Co., Ltd. Mobile eXperience Business is registered with the FDA (registration 3017616353) in Suwon-si Gyeonggi, South Korea. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 31, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017616353
- Address
- 129, Samsung-ro, Yeongtong-gu, Suwon-si Gyeonggi, South Korea, 16677
- Owner or operator
- Samsung Electronics Co., Ltd. (10076996)
- Roles
- Manufacturer
- First device listed
- August 13, 2020
- Registered through
- 2027
- Brand names listed
- Hearing Aid Feature, Hearing Test Feature, Samsung ECG App v1.3 (ECG), Samsung ECG Monitor Application, Samsung ECG Monitor Application with Irregular Heart Rhythm Notification Feature, Samsung Sleep Apnea Feature, Sleep Apnea Feature (v2)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Air-Conduction Hearing Aid Software | SCR | 2 | Manufacturer | accessdata.fda.gov |
| Audiometer | EWO | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph Software For Over-The-Counter Use | QDA | 2 | Manufacturer | accessdata.fda.gov |
| Over-The-Counter Device To Assess Risk Of Sleep Apnea | QZW | 2 | Manufacturer | accessdata.fda.gov |
| Photoplethysmograph Analysis Software For Over-The-Counter Use | QDB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2026 | K261187 | Hearing Aid Feature | SCR | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| July 20, 2026 | K261011 | Sleep Apnea Feature (v2.0) | QZW | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| August 2, 2024 | K240909 | Samsung ECG App v 1.3 (ECG) | QDA | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| February 6, 2024 | DEN230041 | Sleep Apnea Feature | QZW | Unknown | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| May 2, 2023 | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | QDA | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| August 4, 2020 | K201168 | ECG Monitor App | QDA | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Audiometer
- All makers of Photoplethysmograph Analysis Software For Over-The-Counter Use
- All makers of Electrocardiograph Software For Over-The-Counter Use
- All makers of Air-Conduction Hearing Aid Software
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.