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 a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-08-04 under approval 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. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K201168.
When was ECG Monitor App approved by the FDA?
ECG Monitor App received FDA 510(k) clearance on 2020-08-04, under approval number K201168.
What company makes ECG Monitor App?
ECG Monitor App is manufactured by Samsung Electronics Co., Ltd..
What is the FDA product code for ECG Monitor App?
The FDA product code for ECG Monitor App is QDA.
Other Devices by Samsung Electronics Co., Ltd.
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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.