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

    ULTRANS DISPOSABLE INTRAUTERINE

    K Number: K882224 · Decision Oct 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    504

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    Basic Information

    Device Name
    ULTRANS DISPOSABLE INTRAUTERINE
    K Number
    K882224
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Telos Medical Corp.
    Date Received
    May 26, 1988
    Decision Date
    October 12, 1989
    Product Code
    HFN
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HFN Transducer, Pressure, Intrauterine

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    Other Clearances by Telos Medical Corp.

    K Number Device Name
    K920375 DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER
    K920044 DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT
    K914387 TRANSCERVICAL INTRAUTERINE KIT
    K905018 LAB-SITE SAFETY NEEDLE
    K905017 LAB-SITE
    K883832 CATHETER, INTRAUTERINE AND INTRODUCER