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

    FRESH AIR

    K Number: K981047 · Decision Sep 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    2
    Review Days
    545

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    Basic Information

    Device Name
    FRESH AIR
    K Number
    K981047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Colorado Medtech, Inc.
    Date Received
    March 20, 1998
    Decision Date
    September 16, 1999
    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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    Other Clearances by Colorado Medtech, Inc.

    K Number Device Name
    K955890 FIRST MEDIC PULSE OXIMETRY MODULE