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

    BODYGEM, MODEL HB211

    K Number: K010577 · Decision Jan 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    317

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    Basic Information

    Device Name
    BODYGEM, MODEL HB211
    K Number
    K010577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Healthetech, Inc.
    Date Received
    February 27, 2001
    Decision Date
    January 10, 2002
    Product Code
    BZL
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZL Computer, Oxygen-Uptake

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