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

    PEDIATRIC INGESTASCAN

    K Number: K003305 · Decision Dec 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    63

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    Basic Information

    Device Name
    PEDIATRIC INGESTASCAN
    K Number
    K003305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4400
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Adams Electronics, Inc.
    Date Received
    October 20, 2000
    Decision Date
    December 22, 2000
    Product Code
    HPM
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HPM Locator, Metal, Electronic

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