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

    MEDGEM

    K Number: K021605 · Decision Jun 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    MEDGEM
    K Number
    K021605
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Healthetech, Inc.
    Date Received
    May 16, 2002
    Decision Date
    June 14, 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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    Other Clearances by Healthetech, Inc.

    K Number Device Name
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