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

    BITE-BLOCK

    K Number: K833374 · Decision Nov 3, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    18
    Applicant Total
    7
    Review Days
    37

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    Basic Information

    Device Name
    BITE-BLOCK
    K Number
    K833374
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5280
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Sontek Industries, Inc.
    Date Received
    September 27, 1983
    Decision Date
    November 3, 1983
    Product Code
    JAY
    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
    JAY Support, Breathing Tube

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    ENDO-SECURE

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    Other Clearances by Sontek Industries, Inc.

    K Number Device Name
    K833373 BODIA BRONCH-SAF DOUBLE SWIVEL
    K833372 BODIA TRACH-SAF DOUBLE SWIVEL
    K833361 TUBE-TITLE
    K813324 BODAI SWIVEL Y
    K812720 BODAI PATIENT COMMUNICATOR
    K811241 BODAI SUCTION -SAFE 4