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FDA 510(k)

ECG Disposable Lead Wire

K-Number: K170536 · 2017-04-24

ApplicantAPK Technology Co., Ltd.
Decision Date2017-04-24
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG Disposable Lead Wire is a medical device manufactured by APK Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-04-24 under approval number K170536. 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 Disposable Lead Wire?

ECG Disposable Lead Wire is a medical device that received FDA 510(k) clearance on 2017-04-24. It is manufactured by APK Technology Co., Ltd.. The 510(k) number is K170536.

When was ECG Disposable Lead Wire approved by the FDA?

ECG Disposable Lead Wire received FDA 510(k) clearance on 2017-04-24, under approval number K170536.

What company makes ECG Disposable Lead Wire?

ECG Disposable Lead Wire is manufactured by APK Technology Co., Ltd..

What is the FDA product code for ECG Disposable Lead Wire?

The FDA product code for ECG Disposable Lead Wire is DSA.

Other Devices by APK Technology Co., Ltd.

K172981Reusable SpO2 Sensors, Disposable SpO2 Sensors K250425Ultraviolet Phototherapy Device

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. K162432Multi-Link X2 ECG Cable and Lead Wire SystemCarefusion 2200, Inc.

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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