Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ECG Monitor App

K-Number: K201168 · 2020-08-04

ApplicantSamsung Electronics Co., Ltd.
Decision Date2020-08-04
Product CodeQDA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG Monitor App is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-08-04 under 510(k) number K201168. The device is classified under product code QDA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG Monitor App?

ECG Monitor App is a medical device that received FDA 510(k) clearance on 2020-08-04. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K201168.

When did ECG Monitor App receive FDA 510(k) clearance?

ECG Monitor App received FDA 510(k) clearance on 2020-08-04, under 510(k) number K201168.

Who is the listed applicant for ECG Monitor App?

The FDA 510(k) record lists Samsung Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG Monitor App?

The FDA product code for ECG Monitor App is QDA.

Other records listing Samsung Electronics Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261187Hearing Aid FeatureK261011Sleep Apnea Feature (v2.0)K242651GM85K242478GF85 (models GF85-3P, GF85-SP)K240909Samsung ECG App v 1.3 (ECG)K230292Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

View all 25 devices →

Related Devices (Code: QDA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240795Withings ECG AppWithingsK243236WHOOP ECG (electrocardiogram) Feature (1.0)Whoop., Inc.K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.K221774Garmin ECG AppGarmin International, Inc.K201525ECG AppApple, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑