ECG Acquisition Systems
K-Number: K163607 · 2017-12-15
Decision Date2017-12-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ECG Acquisition Systems is a medical device manufactured by Vales & Hills Biomedical Tech. , Ltd.. It received FDA 510(k) clearance on 2017-12-15 under approval number K163607. 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 ECG Acquisition Systems?
ECG Acquisition Systems is a medical device that received FDA 510(k) clearance on 2017-12-15. It is manufactured by Vales & Hills Biomedical Tech. , Ltd.. The 510(k) number is K163607.
When was ECG Acquisition Systems approved by the FDA?
ECG Acquisition Systems received FDA 510(k) clearance on 2017-12-15, under approval number K163607.
What company makes ECG Acquisition Systems?
ECG Acquisition Systems is manufactured by Vales & Hills Biomedical Tech. , Ltd..
What is the FDA product code for ECG Acquisition Systems?
The FDA product code for ECG Acquisition Systems is DPS.
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Official Source
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