FDA 510(k)

ECG Acquisition Systems

K-번호: K163607 · 2017-12-15

신청자Vales & Hills Biomedical Tech. , Ltd.

결정일2017-12-15

제품 코드DPS

자문 위원회CV

결정Substantially Equivalent

기기 요약

ECG Acquisition Systems is the device name listed in this FDA 510(k) record. The listed applicant is Vales & Hills Biomedical Tech. , Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K163607. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ECG Acquisition Systems?

ECG Acquisition Systems is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Vales & Hills Biomedical Tech. , Ltd.. The 510(k) number is K163607.

When did ECG Acquisition Systems receive FDA 510(k) clearance?

ECG Acquisition Systems received FDA 510(k) clearance on 2017-12-15, under 510(k) number K163607.

Who is the listed applicant for ECG Acquisition Systems?

The FDA 510(k) record lists Vales & Hills Biomedical Tech. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG Acquisition Systems?

The FDA product code for ECG Acquisition Systems is DPS.

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ECG Acquisition Systems

기기 요약

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관련 임상시험

관련 기기 (코드: DPS)

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