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

    URINE METER

    K Number: K935578 · Decision Dec 17, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    8
    Applicant Total
    24
    Review Days
    29

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    Basic Information

    Device Name
    URINE METER
    K Number
    K935578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Puritas Health Care, Inc.
    Date Received
    November 18, 1993
    Decision Date
    December 17, 1993
    Product Code
    EXR
    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
    EXR Urinometer, Mechanical

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    Other Clearances by Puritas Health Care, Inc.

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    K935531 OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
    K940074 Y-TYPE BLOOD ADMINISTRATION SET
    K940055 MULTISET
    K940054 MEASURED VOLUME SOLUTION ADMINISTRATION SET
    K935583 SUCTION SET, TRACHAEL
    K940056 WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM
    K935532 TRANSFER SET
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