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

    MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD

    K Number: K093308 · Decision Jan 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    12
    Review Days
    84

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    Basic Information

    Device Name
    MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
    K Number
    K093308
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nidek Medical Products, Inc.
    Date Received
    October 22, 2009
    Decision Date
    January 14, 2010
    Product Code
    CAW
    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
    CAW Generator, Oxygen, Portable

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