LogoFDA 510(k) Search
K Number
K081206
Device Name
HOMELOX
Manufacturer
RESPIRONICS, INC.
Date Cleared
2008-07-28

(90 days)

Product Code
CAW
Regulation Number
868.5440
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The HomeLox is intended to create and store liquid oxygen in a patient's home, so that a patient will be able to fill their liquid portable unit and ambulate. The device is intended only to be a LOX reservoir for filling a portable unit and is not life supporting nor life sustaining.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (HomeLox Portable Oxygen Generator), but it does not include details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment. The letter primarily focuses on the regulatory clearance of the device based on substantial equivalence to legally marketed predicates.

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).