FDA 510(k)

ECG Cable/Leadwires

K-번호: K172797 · 2018-02-28

결정일2018-02-28

제품 코드DSA

자문 위원회CV

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Shenzhen Coreray Technology, Ltd.를 신청인으로 등재한 기타 기록

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

관련 기기 (코드: DSA)

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