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

    PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE

    K Number: K810750 · Decision Mar 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    254
    Review Days
    7

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    Basic Information

    Device Name
    PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
    K Number
    K810750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    General Electric Co.
    Date Received
    March 20, 1981
    Decision Date
    March 27, 1981
    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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