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

    BIOSACA SYSTEM

    K Number: K984580 · Decision Mar 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    62
    Applicant Total
    2
    Review Days
    79

    Basic Information

    Device Name
    BIOSACA SYSTEM
    K Number
    K984580
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIOSYS AB (PUBL)
    Date Received
    December 23, 1998
    Decision Date
    March 12, 1999
    Product Code
    OLV
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLV Standard Polysomnograph With Electroencephalograph

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    Other Clearances by BIOSYS AB (PUBL)

    K Number Device Name
    K991446 BIOSACA SYSTEM, MODEL 800