BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    ANY VIEW PATIENT MONITORS

    K Number: K120193 · Decision Jun 29, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    21
    Review Days
    158

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    Basic Information

    Device Name
    ANY VIEW PATIENT MONITORS
    K Number
    K120193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Biolight Meditech Co., Ltd.
    Date Received
    January 23, 2012
    Decision Date
    June 29, 2012
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    K152739 Electronic Thermometer
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