Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017616353

FEI Number

3017616353

Entity Name

Samsung Electronics Co., Ltd. Mobile eXperience Business

City/State/Country

Suwon-si Gyeonggi, KR

Establishment Address

129, Samsung-ro, Yeongtong-gu, Suwon-si Gyeonggi 16677, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Samsung Electronics Co., Ltd. (Owner Number: 10076996)

Owner / Operator Contact Address

129, Samsung-ro, Yeongtong-gu, Suwon-si, KR-41 16677, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN230041

PMA Number

N/A

All Registered Proprietary Names

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification Feature Samsung ECG App v1.3 (ECG) Samsung Sleep Apnea Feature

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QDA	Electrocardiograph Software For Over-The-Counter Use	Cardiovascular	Class 2	870.2345	2023-10-15
QDB	Photoplethysmograph Analysis Software For Over-The-Counter Use	Cardiovascular	Class 2	870.2790	2023-10-15
QDB	Photoplethysmograph Analysis Software For Over-The-Counter Use	Cardiovascular	Class 2	870.2790	2024-10-09
QDA	Electrocardiograph Software For Over-The-Counter Use	Cardiovascular	Class 2	870.2345	2024-10-09
QZW	Over-The-Counter Device To Assess Risk Of Sleep Apnea	Anesthesiology	Class 2	868.2378	2024-02-20

Official Correspondent

Richard Chon

US Agent Details

Matthew Wiggins Business: Samsung Research America Email: fda.us.agent@samsung.com Phone: (650) 7705804

Related Public Records

Same Entity

Samsung Electronics Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004938766	Samsung HME America, Inc.	Danvers, MA, US
3032116890	SAMSUNG ELECTRONICS CO., LTD.	Seoul, KR
3010300212	Samsung Electronics Co., Ltd.	Suwon-si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K123106	Samsung Electronics Co., Ltd.	DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A	2013-06-20
K243236	Whoop., Inc.	WHOOP ECG (electrocardiogram) Feature (1.0)	2025-04-04

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3007184699	Cardiabase	Nancy Meurthe-et-Moselle, FR
3031627845	Whoop, Inc.	Boston, MA, US
3015134086	TECAN CDMO SOLUTIONS PN SDN. BHD.	Penang Pulau Pinang, MY
3006371704	RR DONNELLEY-SUPPLY CHAIN SOLUTIONS	Plover, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017616353. Last updated year: 2026. Please use registration number 3017616353 when referencing this establishment in official correspondence.