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

    PORTABLE INTENSIVE CARE UNIT

    K Number: K974034 · Decision Mar 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    19
    Review Days
    130

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    Basic Information

    Device Name
    PORTABLE INTENSIVE CARE UNIT
    K Number
    K974034
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Research Laboratories, Inc.
    Date Received
    October 23, 1997
    Decision Date
    March 2, 1998
    Product Code
    DRO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

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    Other Clearances by Medical Research Laboratories, Inc.

    K Number Device Name
    K021168 JUMP START, MODEL 970300
    K012766 PORTABLE INTENSIVE CARE UNIT
    K012030 PORTABLE INTENSIVE CARE UNIT
    K010207 PORTABLE INSTENSIVE CARE UNIT
    K002232 AEDEFIBRILLATOR
    K000712 PORTABLE INTENSIVE CARE UNIT, MODEL PIC
    K983307 MODIFICATION TO PORTABLE INTENSIVE CARE UNIT
    K952085 DPD DEFIBRILLATOR
    K935922 360 SLX ADVISORY DEFIBRILLATOR
    K930548 DPD DEFIBRILLATOR
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