Decision Date2017-04-24
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ECG Disposable Lead Wire is the device name listed in this FDA 510(k) record. The listed applicant is APK Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-04-24 under 510(k) 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. The listed applicant is APK Technology Co., Ltd.. The 510(k) number is K170536.
When did ECG Disposable Lead Wire receive FDA 510(k) clearance?
ECG Disposable Lead Wire received FDA 510(k) clearance on 2017-04-24, under 510(k) number K170536.
Who is the listed applicant for ECG Disposable Lead Wire?
The FDA 510(k) record lists APK Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ECG Disposable Lead Wire?
The FDA product code for ECG Disposable Lead Wire is DSA.
Other records listing APK Technology Co., 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.