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

    PORTABLE INTENSIVE CARE UNIT, MODEL PIC

    K Number: K000712 · Decision Apr 27, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    19
    Review Days
    56

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    Basic Information

    Device Name
    PORTABLE INTENSIVE CARE UNIT, MODEL PIC
    K Number
    K000712
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Research Laboratories, Inc.
    Date Received
    March 2, 2000
    Decision Date
    April 27, 2000
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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    K002232 AEDEFIBRILLATOR
    K983307 MODIFICATION TO PORTABLE INTENSIVE CARE UNIT
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