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

    V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE

    K Number: K110083 · Decision Jan 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    11
    Review Days
    367

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    Basic Information

    Device Name
    V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE
    K Number
    K110083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respironics California, Inc.
    Date Received
    January 11, 2011
    Decision Date
    January 13, 2012
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Respironics California, Inc.

    K Number Device Name
    K110795 V200 INTELLI-TRAK OPTION
    K102054 V200 VENTILATOR
    K082660 V60 VENTILATOR, MODEL V8000
    K072450 ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000
    K071212 ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000
    K051262 ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000
    K041412 ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
    K034032 PLV CONTINUUM VENTILATOR, MODEL P2000
    K022750 PLV CONTINUUM VENTILATOR, MODEL P1000
    K023350 ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
    Search all 11 clearances from Respironics California, Inc. →