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

    ID-Cap System

    K Number: K183052 · Decision Dec 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    399

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    Basic Information

    Device Name
    ID-Cap System
    K Number
    K183052
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6305
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Etectrx, Inc.
    Date Received
    November 2, 2018
    Decision Date
    December 6, 2019
    Product Code
    OZW
    Advisory Committee
    General Hospital
    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
    OZW Ingestible Event Marker

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