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

    GAELTEC MPR SERIES

    K Number: K921062 · Decision Jul 30, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    68
    Applicant Total
    8
    Review Days
    147

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    Basic Information

    Device Name
    GAELTEC MPR SERIES
    K Number
    K921062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Measurements, Inc.
    Date Received
    March 5, 1992
    Decision Date
    July 30, 1992
    Product Code
    FFX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FFX System, Gastrointestinal Motility (Electrical)

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    Other Clearances by Medical Measurements, Inc.

    K Number Device Name
    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
    K801758 MMI/GAELTEC CATHETER INTRAUTERINE
    K801755 MMI/GAELTEC CATHETER TIP PRESSURE