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

    Ecolab POU Water Filter

    K Number: K173164 · Decision Jun 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    10
    Applicant Total
    7
    Review Days
    273

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    Basic Information

    Device Name
    Ecolab POU Water Filter
    K Number
    K173164
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ecolab, Inc.
    Date Received
    September 29, 2017
    Decision Date
    June 29, 2018
    Product Code
    NHV
    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
    NHV System, Water Purification, General Medical Use

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    K142173 NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
    K142080 NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
    K883593 #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY