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

    PHYSIO-DYNE EASI - LAB

    K Number: K922660 · Decision Apr 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    309

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    Basic Information

    Device Name
    PHYSIO-DYNE EASI - LAB
    K Number
    K922660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Physio-Dyne
    Date Received
    June 3, 1992
    Decision Date
    April 8, 1993
    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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