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

    ARISTO MEDICAL MODEL 2101 PATIENT MONITOR

    K Number: K953817 · Decision Nov 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    4
    Review Days
    100

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    Basic Information

    Device Name
    ARISTO MEDICAL MODEL 2101 PATIENT MONITOR
    K Number
    K953817
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aristo Medical Products, Inc.
    Date Received
    August 14, 1995
    Decision Date
    November 22, 1995
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

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    Other Clearances by Aristo Medical Products, Inc.

    K Number Device Name
    K961060 ARISTO ESOPHAGEAL STETHOSCOPE
    K960251 COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR
    K920966 SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)