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K Number
K982943
Device Name
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
Manufacturer
TRANSTRACHEAL SYSTEMS
Date Cleared
1999-07-12

(325 days)

Product Code
NFB
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To conserve oxygen by delivering flow during the inspiration cycle

Device Description

DOC-3000 Demand Oxygen Controller

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "DOC-3000 Demand Oxygen Controller." This type of document primarily confirms substantial equivalence to a predicate device and outlines regulatory conditions. It does not contain information about acceptance criteria, specific device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the information requested in your prompt based on the input document. The document focuses on regulatory approval rather than detailed study results.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).