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K Number
K032018
Device Name
EASY PULSE II OXYGEN CONSERVER
Manufacturer
PRECISION MEDICAL, INC.
Date Cleared
2003-08-25

(56 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

The Precision Medical, Inc. Easy Pulse II Oxygen Conserver is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 5 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.

Device Description

The Precision Medical, Inc. Easy Pulse II Oxygen Conserver is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 5 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, data provenance, expert involvement, adjudication methods, or study types (MRMC or standalone). This document is a 510(k) substantial equivalence letter from the FDA for the "Easy Pulse II Oxygen Conserver", indicating that the device has been cleared for marketing because it is substantially equivalent to a legally marketed predicate device. It briefly describes the device's intended use and regulatory classification.

Therefore, I cannot provide the requested table or answer the specific questions about the study and acceptance criteria as the information is not present in the given document.

§ 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).