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

    MMI/GAELTEC CATHETER TIP PRESSURE

    K Number: K801755 · Decision Aug 13, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    8
    Review Days
    16

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    Basic Information

    Device Name
    MMI/GAELTEC CATHETER TIP PRESSURE
    K Number
    K801755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Medical Measurements, Inc.
    Date Received
    July 28, 1980
    Decision Date
    August 13, 1980
    Product Code
    GWM
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWM Device, Monitoring, Intracranial Pressure

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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
    K801758 MMI/GAELTEC CATHETER INTRAUTERINE