FDA 510(k)

ECG Disposable Lead Wire

K-번호: K170536 · 2017-04-24

결정일2017-04-24

제품 코드DSA

자문 위원회CV

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

APK Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K250425Ultraviolet Phototherapy Device K172981Reusable SpO2 Sensors, Disposable SpO2 Sensors

관련 기기 (코드: DSA)

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