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

    ASAHI AM-R SERIES DIALYZERS

    K Number: K970650 · Decision Sep 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    16
    Review Days
    222

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    Basic Information

    Device Name
    ASAHI AM-R SERIES DIALYZERS
    K Number
    K970650
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Asahi Medical Co., Ltd.
    Date Received
    February 20, 1997
    Decision Date
    September 30, 1997
    Product Code
    MSE
    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
    MSE Hemodialyzer, Re-Use, Low Flux

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    Other Clearances by Asahi Medical Co., Ltd.

    K Number Device Name
    K041726 HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
    K013418 AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
    K001250 APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
    K991512 ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
    K983720 ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
    K914020 MODIFIED ASAHI PAN-SERIES HEMOFILTERS
    K901887 MODIFIED SEPACELL R-SERIES BLOOD FILTERS
    K896976 MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS
    K896664 MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
    K892375 MODIFIED AM-SERIES DIALYZERS
    Search all 16 clearances from Asahi Medical Co., Ltd. →