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

    NEONATAL BREATHING CIRCUIT SYSTEM

    K Number: K801087 · Decision May 23, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    NEONATAL BREATHING CIRCUIT SYSTEM
    K Number
    K801087
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Isothermal Systems, Inc.
    Date Received
    May 7, 1980
    Decision Date
    May 23, 1980
    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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    PRIMA VOLUMN VENTILATORSS

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    Other Clearances by Isothermal Systems, Inc.

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