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

    FLOTEC OXYSAVRR (S)

    K Number: K970371 · Decision Jul 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    70
    Applicant Total
    2
    Review Days
    160

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    Basic Information

    Device Name
    FLOTEC OXYSAVRR (S)
    K Number
    K970371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Flotec, Inc.
    Date Received
    January 31, 1997
    Decision Date
    July 10, 1997
    Product Code
    NFB
    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
    NFB Conserver, Oxygen

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    Other Clearances by Flotec, Inc.

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