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

    PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400

    K Number: K945985 · Decision Jul 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    6
    Review Days
    207

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    Basic Information

    Device Name
    PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400
    K Number
    K945985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Burdick, Inc.
    Date Received
    December 8, 1994
    Decision Date
    July 3, 1995
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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