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

    VENTNET; CENTRAL MONITORING STATION

    K Number: K963633 · Decision Dec 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    13
    Applicant Total
    110
    Review Days
    96

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    Basic Information

    Device Name
    VENTNET; CENTRAL MONITORING STATION
    K Number
    K963633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Puritan Bennett Corp.
    Date Received
    September 11, 1996
    Decision Date
    December 16, 1996
    Product Code
    MOD
    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
    MOD Accessory To Continuous Ventilator (Respirator)

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    Other Clearances by Puritan Bennett Corp.

    K Number Device Name
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    K023225 PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
    K022103 PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
    K001646 PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
    K002001 BREEZE SLEEPGEAR WITH DREAMSEAL
    K993071 PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
    K993220 PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
    K993088 PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
    K984535 PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
    Search all 110 clearances from Puritan Bennett Corp. →