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

    MMI/GAELTEC CATHETER TIP PRESS. TRANSDU

    K Number: K801757 · Decision Aug 27, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    8
    Review Days
    30

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    Basic Information

    Device Name
    MMI/GAELTEC CATHETER TIP PRESS. TRANSDU
    K Number
    K801757
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical Measurements, Inc.
    Date Received
    July 28, 1980
    Decision Date
    August 27, 1980
    Product Code
    FES
    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
    FES Recorder, External, Pressure, Amplifier & Transducer

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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
    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