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

    CARDIOVIT AT-1, P-80

    K Number: K946205 · Decision Mar 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    10
    Review Days
    85

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    Basic Information

    Device Name
    CARDIOVIT AT-1, P-80
    K Number
    K946205
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Schiller America, Inc.
    Date Received
    December 21, 1994
    Decision Date
    March 16, 1995
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    K896120 SCHILLER MODEL SP-100 SPIROVIT(TM)