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

    ATRIAL/VENTRICULAR SEQENTIAL #080-20000

    K Number: K801799 · Decision Jan 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    5
    Review Days
    157

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    Basic Information

    Device Name
    ATRIAL/VENTRICULAR SEQENTIAL #080-20000
    K Number
    K801799
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medical Testing System, Inc.
    Date Received
    July 29, 1980
    Decision Date
    January 2, 1981
    Product Code
    LDF
    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
    LDF Electrode, Pacemaker, Temporary

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    Other Clearances by Medical Testing System, Inc.

    K Number Device Name
    K801802 ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE
    K801800 UNIVERSAL TEMP. PACING ELECT. #080-10000
    K791797 MTS CATHETER ADAPTER FOR GUIDANCE ENTRY
    K770641 MINI-CONER TM