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

    DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1

    K Number: K981378 · Decision Nov 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    9
    Review Days
    201

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    Basic Information

    Device Name
    DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
    K Number
    K981378
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Datex-Engstrom, Inc.
    Date Received
    April 16, 1998
    Decision Date
    November 3, 1998
    Product Code
    DRT
    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
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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