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

    MODIFIED OSTEOANALYZER (# SPSHA110/220)

    K Number: K891582 · Decision Sep 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    144
    Applicant Total
    2
    Review Days
    176

    Basic Information

    Device Name
    MODIFIED OSTEOANALYZER (# SPSHA110/220)
    K Number
    K891582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    OSTEON, INC.
    Date Received
    March 20, 1989
    Decision Date
    September 12, 1989
    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
    K843922 OSTEON BONE MINERAL ANALYZER