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

    MDI 2000 - PULSE GENERATOR

    K Number: K850791 · Decision Jun 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    7
    Review Days
    113

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    Basic Information

    Device Name
    MDI 2000 - PULSE GENERATOR
    K Number
    K850791
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Micromedical Devices, Inc.
    Date Received
    February 26, 1985
    Decision Date
    June 19, 1985
    Product Code
    DRO
    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
    DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

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    Other Clearances by Micromedical Devices, Inc.

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    K936097 VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL
    K936086 STERILE VIDEO CAMERA COVER AND DRAPE
    K834262 TRANS-PACE