BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ZYMED TELEMETRY SYSTEM; MODEL T8010

    K Number: K951370 · Decision Oct 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    7
    Review Days
    193

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    Basic Information

    Device Name
    ZYMED TELEMETRY SYSTEM; MODEL T8010
    K Number
    K951370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zymed Medical Instrumentation
    Date Received
    March 27, 1995
    Decision Date
    October 6, 1995
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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    Other Clearances by Zymed Medical Instrumentation

    K Number Device Name
    K002004 ZYBIT
    K992197 MODIFICATION TO ZYMED HOLTER 2000
    K990170 HOLTER 2000
    K984089 ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW
    K955015 ZYMED HOLTER SCANNER MODEL 2010
    K930894 MULTITRAK-PLUS