BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NEONATAL VENTILATOR CIRCUIT

    K Number: K903083 · Decision Dec 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    15
    Review Days
    168

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    Basic Information

    Device Name
    NEONATAL VENTILATOR CIRCUIT
    K Number
    K903083
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Hudson Respiratory Care, Inc.
    Date Received
    July 12, 1990
    Decision Date
    December 27, 1990
    Product Code
    BZO
    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
    BZO Set, Tubing And Support, Ventilator (W Harness)

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    K993355 HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
    K994352 SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
    K964719 HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
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