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FDA 510(k)

ECG Cable/Leadwires

K-Number: K172797 · 2018-02-28

ApplicantShenzhen Coreray Technology, Ltd.
Decision Date2018-02-28
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG Cable/Leadwires is a medical device manufactured by Shenzhen Coreray Technology, Ltd.. It received FDA 510(k) clearance on 2018-02-28 under approval 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. It is manufactured by Shenzhen Coreray Technology, Ltd.. The 510(k) number is K172797.

When was ECG Cable/Leadwires approved by the FDA?

ECG Cable/Leadwires received FDA 510(k) clearance on 2018-02-28, under approval number K172797.

What company makes ECG Cable/Leadwires?

ECG Cable/Leadwires is manufactured by Shenzhen Coreray Technology, Ltd..

What is the FDA product code for ECG Cable/Leadwires?

The FDA product code for ECG Cable/Leadwires is DSA.

Other Devices by Shenzhen Coreray Technology, Ltd.

K173368Reusable & Disposable SpO2 Sensors K192404Patient Monitoring Cable (SpO2 Extension Cable)

Related Devices (Code: DSA)

K153188Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd. K152947Disposable Temporary Pacing CableTiger Medical Products K172591Fixed Patient Leads ECG Cable (Model 3153)Boston Scientific Corporation K162768ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cablesIntegral Process Sas K163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. K170536ECG Disposable Lead WireAPK Technology Co., Ltd.

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.

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