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

    RESTROSPECTIVE ECG MEMORY MODULE

    K Number: K831406 · Decision Jul 7, 1983
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    66

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    Basic Information

    Device Name
    RESTROSPECTIVE ECG MEMORY MODULE
    K Number
    K831406
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Cardiac Evaluation Center, Inc.
    Date Received
    May 2, 1983
    Decision Date
    July 7, 1983
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

    Other Clearances by Cardiac Evaluation Center, Inc.

    K Number Device Name
    K954163 RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER