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

    MCPULSE

    K Number: K023238 · Decision Feb 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    7
    Review Days
    145

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    Basic Information

    Device Name
    MCPULSE
    K Number
    K023238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2780
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meridian Co., Ltd.
    Date Received
    September 27, 2002
    Decision Date
    February 19, 2003
    Product Code
    JOM
    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
    JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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    Other Clearances by Meridian Co., Ltd.

    K Number Device Name
    K102375 LUCIA
    K081962 LAPEX BCS
    K034009 LAPEX 2000
    K020360 ABR-2000
    K010897 MERIDIAN-PORTABLE
    K001347 MERIDIAN-II AND MERDIAN-PLUS