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

    TRACHEOSTOMY CARE TRAY

    K Number: K932016 · Decision Nov 3, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    16
    Review Days
    194

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    Basic Information

    Device Name
    TRACHEOSTOMY CARE TRAY
    K Number
    K932016
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Clinipad Corp.
    Date Received
    April 23, 1993
    Decision Date
    November 3, 1993
    Product Code
    JOH
    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
    JOH Tube Tracheostomy And Tube Cuff

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    Other Clearances by Clinipad Corp.

    K Number Device Name
    K931560 CARDIAC CATHETERIZATION TRAY
    K931668 PICC INSERTION TRAY
    K932071 I.V. START KIT
    K932010 V.A.D. ACCESS KIT
    K932036 LACERATION TRAY
    K862562 PUNCH BIOPSY KIT
    K862563 TRACHEOSTOMY CLEANSING SOLUTION
    K833075 WET DRESSING KIT
    K833432 CATHETER INSERTION KIT
    K830476 OR PREP KIT
    Search all 16 clearances from Clinipad Corp. →