ECG Cable
K-Number: K191428 · 2019-11-27
Decision Date2019-11-27
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ECG Cable is a medical device manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-11-27 under approval number K191428. 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 Cable?
ECG Cable is a medical device that received FDA 510(k) clearance on 2019-11-27. It is manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. The 510(k) number is K191428.
When was ECG Cable approved by the FDA?
ECG Cable received FDA 510(k) clearance on 2019-11-27, under approval number K191428.
What company makes ECG Cable?
ECG Cable is manufactured by Shenzhen Changke Connect Electronics Co., Ltd..
What is the FDA product code for ECG Cable?
The FDA product code for ECG Cable is DSA.
Other Devices by Shenzhen Changke Connect 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.