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

    TUBING, NONINVASIVE

    K Number: K945978 · Decision Jan 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    206
    Same Product Code
    26
    Applicant Total
    8
    Review Days
    34

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    Basic Information

    Device Name
    TUBING, NONINVASIVE
    K Number
    K945978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Endoscopic Technologies, Inc.
    Date Received
    December 8, 1994
    Decision Date
    January 11, 1995
    Product Code
    GAZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GAZ Tubing, Noninvasive

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