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K Number
K981249
Device Name
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D
Manufacturer
INSTRUMENTATION INDUSTRIES, INC.
Date Cleared
1998-11-23

(231 days)

Product Code
CAF
Regulation Number
868.5630
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The RTC 21 Series MDI adapters are intended for use in intermittent aerosol therapy to I ho re o osol medications (in compressed cannister MDIs) via the proximal end of an endotracheal tube.

Device Description

RTC 21-A is reusable. RTC 21-D is single patient use.

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Metered Dose Inhaler Adapter). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request. The document primarily discusses regulatory approval based on substantial equivalence to a predicate device. Therefore, I cannot extract the requested information from this text.

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).