Electrocardiograph, model: ECG301
K-Number: K232816 · 2024-06-07
Decision Date2024-06-07
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Electrocardiograph, model: ECG301 is a medical device manufactured by Shenzhen LE Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-07 under approval number K232816. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Electrocardiograph, model: ECG301?
Electrocardiograph, model: ECG301 is a medical device that received FDA 510(k) clearance on 2024-06-07. It is manufactured by Shenzhen LE Medical Technology Co., Ltd.. The 510(k) number is K232816.
When was Electrocardiograph, model: ECG301 approved by the FDA?
Electrocardiograph, model: ECG301 received FDA 510(k) clearance on 2024-06-07, under approval number K232816.
What company makes Electrocardiograph, model: ECG301?
Electrocardiograph, model: ECG301 is manufactured by Shenzhen LE Medical Technology Co., Ltd..
What is the FDA product code for Electrocardiograph, model: ECG301?
The FDA product code for Electrocardiograph, model: ECG301 is DPS.
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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.