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

    MRI COMPATIBLE MONITOR AND ACCESSORIES

    K Number: K980362 · Decision Jun 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    9
    Review Days
    152

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    Basic Information

    Device Name
    MRI COMPATIBLE MONITOR AND ACCESSORIES
    K Number
    K980362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Datex-Engstrom, Inc.
    Date Received
    January 29, 1998
    Decision Date
    June 30, 1998
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    Other Clearances by Datex-Engstrom, Inc.

    K Number Device Name
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    K981378 DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
    K973985 AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
    K974792 CS/3(TM) MONITORS*
    K980384 TRIP TONOMETRY CATHETER, 18F
    K974747 CS/3 ARRHYTHMIA WORKSTATION
    K974101 DATEX-ENGSTROM NETWORK