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

    ANS 2000 ECG MONITOR AND RESPIRATION PACER

    K Number: K973426 · Decision Aug 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    19
    Review Days
    336

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    Basic Information

    Device Name
    ANS 2000 ECG MONITOR AND RESPIRATION PACER
    K Number
    K973426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    D. E. Hokanson, Inc.
    Date Received
    September 10, 1997
    Decision Date
    August 12, 1998
    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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