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

    ITO ACUPUNCTURE NEEDLES

    K Number: K963194 · Decision Aug 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    90
    Applicant Total
    6
    Review Days
    8

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    Basic Information

    Device Name
    ITO ACUPUNCTURE NEEDLES
    K Number
    K963194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5580
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oms Medical Supplies, Inc.
    Date Received
    August 15, 1996
    Decision Date
    August 23, 1996
    Product Code
    MQX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQX Needle, Acupuncture, Single Use

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    Other Clearances by Oms Medical Supplies, Inc.

    K Number Device Name
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    K884210 TX-7 (TENS) (IC-1107)