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

    SABRATEK PATIENT HOME MANAGEMENT SYSTEM

    K Number: K980619 · Decision Aug 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    7
    Review Days
    183

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    Basic Information

    Device Name
    SABRATEK PATIENT HOME MANAGEMENT SYSTEM
    K Number
    K980619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sabratek Corp.
    Date Received
    February 18, 1998
    Decision Date
    August 20, 1998
    Product Code
    MHX
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by Sabratek Corp.

    K Number Device Name
    K983355 SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR
    K980751 SABRATEK 4040 INFUSION PUMP
    K955258 3030 INFUSION PUMP
    K944293 SABRATEK SABSIL SETS
    K941984 SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP
    K914589 SABRATEK 3030 INFUSION PUMP