BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇰 Denmark

    OXYGEN CATHETERS

    K Number: K896731 · Decision Mar 30, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    7
    Applicant Total
    7
    Review Days
    120

    Basic Information

    Device Name
    OXYGEN CATHETERS
    K Number
    K896731
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5350
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    UNOPLAST A/S
    Date Received
    November 30, 1989
    Decision Date
    March 30, 1990
    Product Code
    BZB
    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
    BZB Catheter, Nasal, Oxygen

    Similar 510(k) Clearances

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

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    NASAL OXYGEN CATHETER

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    OXYGEN CATHETER

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    CONPHAR OXYGEN CATHETER-STERILE

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    Other Clearances by UNOPLAST A/S

    K Number Device Name
    K896734 FEEDING TUBE
    K896729 NELATON-, FEMALE - OR TIEMANN CATHETER
    K896732 UNOMETER 500
    K896730 SUCTION CATHETER STRAIGHT/COUDE
    K896733 VACCON
    K802248 DISARP ORIGINAL