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

    MMI/GAELTEC CATHETER INTRAUTERINE

    K Number: K801758 · Decision Aug 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    8
    Review Days
    17

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    Basic Information

    Device Name
    MMI/GAELTEC CATHETER INTRAUTERINE
    K Number
    K801758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Medical Measurements, Inc.
    Date Received
    July 28, 1980
    Decision Date
    August 14, 1980
    Product Code
    KXO
    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
    KXO Monitor, Pressure, Intrauterine

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    Other Clearances by Medical Measurements, Inc.

    K Number Device Name
    K921062 GAELTEC MPR SERIES
    K902097 MODEL TR RECTAL SUCTION BIOPSY TUBE
    K863479 MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL
    K801757 MMI/GAELTEC CATHETER TIP PRESS. TRANSDU
    K801756 MMI/GAELTEC CATHETER TIP TRANSDUC
    K801880 MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS
    K801755 MMI/GAELTEC CATHETER TIP PRESSURE