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

    HS17/HS18 SERIES MONITORS

    K Number: K820670 · Decision Apr 9, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    8
    Review Days
    29

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    Basic Information

    Device Name
    HS17/HS18 SERIES MONITORS
    K Number
    K820670
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medtel Pty. , Ltd.
    Date Received
    March 11, 1982
    Decision Date
    April 9, 1982
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Medtel Pty. , Ltd.

    K Number Device Name
    K832356 PORTABLE OPERAT. RM. MONITORS HS30/40
    K820671 CM10 CENTRAL MONITORING SYSTEM
    K820399 HS20 PORT. OPERATING ROOM MONITOR
    K802184 HS10 PORTABLE OPERATING ROOM MONITOR
    K800243 D668 & D664 CENTRAL MONITORING SYSTEMS
    K791839 H59 CRITICAL CARE MONITOR
    K791838 HSH/H512 ADULT PHYSIOLOGICAL MONITORS