BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    TECHFIL

    K Number: K954801 · Decision Jan 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    98

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    Basic Information

    Device Name
    TECHFIL
    K Number
    K954801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Technimeca Medic, Inc.
    Date Received
    October 19, 1995
    Decision Date
    January 25, 1996
    Product Code
    CAD
    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
    CAD Vaporizer, Anesthesia, Non-Heated

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    Other Clearances by Technimeca Medic, Inc.

    K Number Device Name
    K953748 TECHNOFIL