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

    KENDALL SHERIDAN CPAP SYSTEM

    K Number: K953511 · Decision Oct 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    72
    Same Product Code
    79
    Applicant Total
    66
    Review Days
    92

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    Basic Information

    Device Name
    KENDALL SHERIDAN CPAP SYSTEM
    K Number
    K953511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5965
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Kendall Healthcare Products Co. Div.Of Tyco Health
    Date Received
    July 26, 1995
    Decision Date
    October 26, 1995
    Product Code
    BYE
    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
    BYE Attachment, Breathing, Positive End Expiratory Pressure

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    Other Clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

    K Number Device Name
    K973763 KENDALL CURITY IODOFORM PACKING STRIP
    K973511 KENDALL CURITY PETROLATUM GAUZE
    K973507 KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
    K973619 KENDALL CURITY NON-ADHERING DRESSING
    K973509 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
    K973546 KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
    K970266 KENDALL HYDROPHILIC POWDER WOUND DRESSING
    K963446 KENDALL DUAL LUMEN CATHETER
    K964899 KENDALL CURITY URETERAL CATHETER
    K964519 CURITY THORACENTESIS TRAY
    Search all 66 clearances from Kendall Healthcare Products Co. Div.Of Tyco Health →