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

    CUSTO PORT 24-H ECG AMBULATORY RECORDER

    K Number: K854115 · Decision Jan 27, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    2
    Review Days
    111

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    Basic Information

    Device Name
    CUSTO PORT 24-H ECG AMBULATORY RECORDER
    K Number
    K854115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Versacor, Inc.
    Date Received
    October 8, 1985
    Decision Date
    January 27, 1986
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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    Other Clearances by Versacor, Inc.

    K Number Device Name
    K854745 CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM