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510(k) Data Aggregation

    K Number
    K974758
    Device Name
    HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
    Manufacturer
    HYDROX LABORATORIES
    Date Cleared
    1998-03-09

    (80 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K843166,K943828
    Why did this record match?
    Reference Devices :

    K843166, K825510A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not for injection, for suction catheter procedures. Hydrox Sterile Water is intended to be used in device lubrication, moistening and flusling. It is not intended for wound irrigation or IV or IM administration and is labeled as such.
    The intended use of this device is the same as the intended use of similar devices currently in the market.

    Device Description

    Hydrox Sterile Water 4 oz. Cup 120 ml, Trade Name: Hvdrox Sterile Water 100 ml Bottle

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Hydrox Sterile Water." This document does not describe an AI/ML medical device, nor does it contain any information related to acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods for such a device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the input document does not contain this type of information. It is a regulatory clearance letter for a sterile water product, not an AI/ML device study report.

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