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

    BODY BOX 5500

    K Number: K022636 · Decision Jan 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    10
    Applicant Total
    6
    Review Days
    158

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    Basic Information

    Device Name
    BODY BOX 5500
    K Number
    K022636
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1760
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Morgan Scientific, Inc.
    Date Received
    August 8, 2002
    Decision Date
    January 13, 2003
    Product Code
    JEH
    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
    JEH Plethysmograph, Volume

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