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

    OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2

    K Number: K100899 · Decision Sep 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    20
    Applicant Total
    6
    Review Days
    166

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    Basic Information

    Device Name
    OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
    K Number
    K100899
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Keymed (Medical & Industrial Equipment), Ltd.
    Date Received
    March 31, 2010
    Decision Date
    September 13, 2010
    Product Code
    FEQ
    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
    FEQ Pump, Air, Non-Manual, For Endoscope

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    Other Clearances by Keymed (Medical & Industrial Equipment), Ltd.

    K Number Device Name
    K011725 OLYMPUS SUCTION PUMP, MODEL KV-5
    K000948 OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
    K962528 OLYMPUS MOBILE CHAIR/COUCH
    K930852 OLYMPUS SUCTION PUMP MODEL KV-4
    K881478 MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS