BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AROMAPATCH

    K Number: K984345 · Decision Mar 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    AROMAPATCH
    K Number
    K984345
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5220
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Envis, Inc.
    Date Received
    December 4, 1998
    Decision Date
    March 19, 1999
    Product Code
    LRD
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRD Applicator, Ent Drug

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