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

    RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC

    K Number: K012020 · Decision Aug 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    6
    Review Days
    54

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    Basic Information

    Device Name
    RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC
    K Number
    K012020
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Non-Invasive Monitoring Systems, Inc.
    Date Received
    June 28, 2001
    Decision Date
    August 21, 2001
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Non-Invasive Monitoring Systems, Inc.

    K Number Device Name
    K001369 RESPIEVENTS, VERSION 4.2
    K942852 RESPITRACE PT
    K942771 RESPIEVENTS
    K903011 RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL
    K884959 RESPITRAK