LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971134
    Device Name
    VISTA EYESHOWER
    Manufacturer
    JOHN BRANCH
    Date Cleared
    1997-11-04

    (221 days)

    Product Code
    LXQ
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VISTA EYESHOWER

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

    The Vista EYESHOWER is a single-use, disposable device intended for use with Iriqate, sterile, isotonic, buffered eye wash (Optopics Laboratories Corp., Fairton, N.J.), supplied in a 1-ounce Boston round bottle for irrigating the eye to help relieve discomfort caused by foreign material, air pollutants, or chlorinated water.

    For Over-The-Counter use.

    Device Description

    The Vista EYESHOWER is a single-use, disposable device intended for use with Iriqate, sterile, isotonic, buffered eye wash (Optopics Laboratories Corp., Fairton, N.J.), supplied in a 1-ounce Boston round bottle for irrigating the eye.

    AI/ML Overview

    The provided documents are FDA 510(k) letters for the Vista EYESHOWER, a single-use, disposable device for eye irrigation. These letters confirm the device's substantial equivalence to a predicate device but do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot provide the requested information based on the given input. The documents are purely administrative communications regarding regulatory clearance.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1