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FDA 510(k)

ECG Cables and Leadwires

Número K: K201359 · 2020-10-01

RequerenteXinkang Medical Instrument Co. , Ltd.
Data da decisão2020-10-01
Código do produtoDSA
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

ECG Cables and Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Xinkang Medical Instrument Co. , Ltd.. It received FDA 510(k) clearance on 2020-10-01 under 510(k) number K201359. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ECG Cables and Leadwires?

ECG Cables and Leadwires is a medical device that received FDA 510(k) clearance on 2020-10-01. The listed applicant is Xinkang Medical Instrument Co. , Ltd.. The 510(k) number is K201359.

When did ECG Cables and Leadwires receive FDA 510(k) clearance?

ECG Cables and Leadwires received FDA 510(k) clearance on 2020-10-01, under 510(k) number K201359.

Who is the listed applicant for ECG Cables and Leadwires?

The FDA 510(k) record lists Xinkang Medical Instrument Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG Cables and Leadwires?

The FDA product code for ECG Cables and Leadwires is DSA.

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Outros registros que listam Xinkang Medical Instrument Co. , Ltd. como candidato(a)

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K201360Reusable and Disposable SpO2 Sensors

Dispositivos Relacionados (Código: DSA)

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K254114Baylis Connector CableBaylis Medical Technologies, Inc.K252827IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)Drägerwerk AG & Co. KGaAK251669IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapterShanghai Draeger Medical Instrument Co., Ltd.K242986SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd.K243545Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, SnPhilips Medizin Systeme Böblingen GmbHK240087RT Carbon ECG LeadsIvy Biomedical Systems, Inc.

Fonte oficial

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