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

    SIMS CPAP SYSTEM

    K Number: K953485 · Decision Oct 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    72
    Same Product Code
    79
    Applicant Total
    22
    Review Days
    94

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    Basic Information

    Device Name
    SIMS CPAP SYSTEM
    K Number
    K953485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5965
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Industries Medical Systems, Inc.
    Date Received
    July 24, 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 Smiths Industries Medical Systems, Inc.

    K Number Device Name
    K972385 FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
    K965017 REGIONAL ANESTHESIA TRAYS
    K962175 PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
    K962931 SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
    K963570 SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
    K960429 PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
    K953483 SIMS BLUE LINE ENDOBRONCHIAL TUBE
    K932946 WALLACE IV CANNULA
    K932947 WALLACE Y-CAN
    K952516 PRO-VENT, LINE DRAW, PULSATOR
    Search all 22 clearances from Smiths Industries Medical Systems, Inc. →