BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Med-link Disposable ECG Cable and Leadwires

    K Number: K220447 · Decision Jun 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    14
    Review Days
    132

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Med-link Disposable ECG Cable and Leadwires
    K Number
    K220447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Med-Link Electronics Tech Co., Ltd.
    Date Received
    February 16, 2022
    Decision Date
    June 28, 2022
    Product Code
    DSA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DSA), ordered by most recent decision date.

    Baylis Connector Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IBP 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)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IBP 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 adapter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SpO2 Extension Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Philips 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, Sn

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RT Carbon ECG Leads

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Shenzhen Med-Link Electronics Tech Co., Ltd.

    K Number Device Name
    K251160 Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
    K220448 Disposable Non-invasive EEG Sensor
    K212752 Med-link Pulse Oximeter
    K210441 Incontinence Probe
    K202743 Med-Link Temp-pulse Oximeter
    K193338 Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
    K181154 Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
    K182667 Med-link Temperature Probes
    K173869 Med-link Reusable Blood Pressure Cuff
    K160530 Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
    Search all 14 clearances from Shenzhen Med-Link Electronics Tech Co., Ltd. →