Decision Date2018-02-28
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ECG Cable/Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Coreray Technology, Ltd.. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K172797. 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/Leadwires?
ECG Cable/Leadwires is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Shenzhen Coreray Technology, Ltd.. The 510(k) number is K172797.
When did ECG Cable/Leadwires receive FDA 510(k) clearance?
ECG Cable/Leadwires received FDA 510(k) clearance on 2018-02-28, under 510(k) number K172797.
Who is the listed applicant for ECG Cable/Leadwires?
The FDA 510(k) record lists Shenzhen Coreray Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ECG Cable/Leadwires?
The FDA product code for ECG Cable/Leadwires is DSA.
Other records listing Shenzhen Coreray Technology, Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.