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

    TODD MEDICAL/SKILLED CARE PRODUCTS

    K Number: K873499 · Decision Nov 24, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    6
    Review Days
    85

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    Basic Information

    Device Name
    TODD MEDICAL/SKILLED CARE PRODUCTS
    K Number
    K873499
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Todd Medical, Inc.
    Date Received
    August 31, 1987
    Decision Date
    November 24, 1987
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BTO), ordered by most recent decision date.

    5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm

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    Pilling Tracheostomy Tubes

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    Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm

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    BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

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    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

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    WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

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    Other Clearances by Todd Medical, Inc.

    K Number Device Name
    K873288 CLOSED FOLEY CATHETER SYSTEM
    K873287 IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE)
    K873469 TODD MEDICAL/SKILLED CARE PRODUCTS
    K850646 ECLIPSE SELF ADHERING ELECTRODE
    K850004 TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF