BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SINGLE DOSE GAS INJECTOR

    K Number: K923397 · Decision Sep 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    66

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    Basic Information

    Device Name
    SINGLE DOSE GAS INJECTOR
    K Number
    K923397
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2620
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Escalon Medical Trek
    Date Received
    July 10, 1992
    Decision Date
    September 14, 1992
    Product Code
    BXX
    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
    BXX Calibrator, Pressure, Gas

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