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

    Patient Cables and Leadwires , Disposable ECG Leadwires

    K Number: K182327 · Decision Jan 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    5
    Review Days
    156

    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
    Patient Cables and Leadwires , Disposable ECG Leadwires
    K Number
    K182327
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orantech, Inc.
    Date Received
    August 27, 2018
    Decision Date
    January 30, 2019
    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 Orantech, Inc.

    K Number Device Name
    K173194 Temperature Probe
    K181270 Disposable SpO2 Sensors, Reusable SpO2 Sensors
    K173197 Reusable NIBP Cuff
    K171828 ETCO2 Sensor