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

    OLYMPUS ISE MODULE FOR AU5000

    K Number: K893628 · Decision Aug 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    37
    Applicant Total
    142
    Review Days
    92

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    Basic Information

    Device Name
    OLYMPUS ISE MODULE FOR AU5000
    K Number
    K893628
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Olympus Corp.
    Date Received
    May 11, 1989
    Decision Date
    August 11, 1989
    Product Code
    CGZ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CGZ Electrode, Ion-Specific, Chloride

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    Other Clearances by Olympus Corp.

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    K931763 HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
    K934835 FLOVAL
    K931764 HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES
    K915857 FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE
    K931994 RESECTOSCOPE SHEATH
    K933992 OLYMPUS SCLEROTHERAPY BALLOON
    K934361 OLYMPUS CREATININE REAGENT
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