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510(k) Data Aggregation

    K Number
    K183293
    Device Name
    VERIFY VH202 Indicator Tape
    Manufacturer
    STERIS Corporation
    Date Cleared
    2019-01-04

    (38 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K231488
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a sterilization process indicator. It is a regulatory document and does not contain information about the device's performance, acceptance criteria, or any studies proving its effectiveness in the context of the requested details about an AI/medical device study.

    Therefore, I cannot extract the information required to populate the fields about acceptance criteria, study details, sample sizes, expert involvement, or ground truth.

    The provided text does not contain the information needed to answer your questions regarding the acceptance criteria and the study proving the device meets those criteria.

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