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

    TRACHEOSTOMY CARE SET WITH GLOVES

    K Number: K923834 · Decision Dec 10, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    14
    Review Days
    132

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    Basic Information

    Device Name
    TRACHEOSTOMY CARE SET WITH GLOVES
    K Number
    K923834
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    American Healthcare Corp.
    Date Received
    July 31, 1992
    Decision Date
    December 10, 1992
    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)

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    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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    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

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    Other Clearances by American Healthcare Corp.

    K Number Device Name
    K924192 I.V. START KIT (AHC-50-54954
    K923938 IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER
    K923939 IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER
    K923940 IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE
    K923941 IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE
    K924193 TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
    K924191 TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
    K924195 TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
    K924194 TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
    K905136 GAUZE SPONGES, INTERNAL AND EXTERNAL
    Search all 14 clearances from American Healthcare Corp. →