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

    TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE

    K Number: K952083 · Decision Oct 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    56
    Applicant Total
    1
    Review Days
    537

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    Basic Information

    Device Name
    TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE
    K Number
    K952083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Clover Medical Equipment Services, Inc.
    Date Received
    May 3, 1995
    Decision Date
    October 21, 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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