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

    OSTEON BONE MINERAL ANALYZER

    K Number: K843922 · Decision Apr 2, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    2
    Review Days
    179

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    Basic Information

    Device Name
    OSTEON BONE MINERAL ANALYZER
    K Number
    K843922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Osteon, Inc.
    Date Received
    October 5, 1984
    Decision Date
    April 2, 1985
    Product Code
    KGI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KGI Densitometer, Bone

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    Other Clearances by Osteon, Inc.

    K Number Device Name
    K891582 MODIFIED OSTEOANALYZER (# SPSHA110/220)