ECG Cables and Leadwires
K-Number: K201359 · 2020-10-01
Decision Date2020-10-01
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ECG Cables and Leadwires is a medical device manufactured by Xinkang Medical Instrument Co. , Ltd.. It received FDA 510(k) clearance on 2020-10-01 under approval number K201359. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ECG Cables and Leadwires?
ECG Cables and Leadwires is a medical device that received FDA 510(k) clearance on 2020-10-01. It is manufactured by Xinkang Medical Instrument Co. , Ltd.. The 510(k) number is K201359.
When was ECG Cables and Leadwires approved by the FDA?
ECG Cables and Leadwires received FDA 510(k) clearance on 2020-10-01, under approval number K201359.
What company makes ECG Cables and Leadwires?
ECG Cables and Leadwires is manufactured by Xinkang Medical Instrument Co. , Ltd..
What is the FDA product code for ECG Cables and Leadwires?
The FDA product code for ECG Cables and Leadwires is DSA.
Other Devices by Xinkang Medical Instrument 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.