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510(k) Data Aggregation

    K Number
    K991355
    Device Name
    METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    2000-01-27

    (283 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE

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

    The RTC Series Metered Dose Inhaler (MDI) Adapters are actuators for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers. The RTC Series MDI Adapters are intended for use only when connected to ventilator tubing or tracheal tubes.

    The RTC 15-D, RTC 22-D, and RTC 23-D models are intended for single patient use.

    The RTC 22-A and RTC 23-A models are reusable and may be reprocessed.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding a Metered Dose Inhaler Adapter (K991355). It does not contain information about acceptance criteria, study details, or performance data for the device. The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information. This document is a regulatory clearance letter, not a study report or technical specification.

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