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

    PURITAN-BENNETT COMPANION 320 I/E

    K Number: K934804 · Decision Feb 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    110
    Review Days
    508

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    Basic Information

    Device Name
    PURITAN-BENNETT COMPANION 320 I/E
    K Number
    K934804
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Puritan Bennett Corp.
    Date Received
    October 7, 1993
    Decision Date
    February 27, 1995
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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    Other Clearances by Puritan Bennett Corp.

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    K993220 PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
    K993088 PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
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