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K Number
K983627
Device Name
VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
Manufacturer
INVACARE CORP.
Date Cleared
1999-10-22

(372 days)

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

This device is indicated for supplemental Medical Oxygen for treatment of Respiratory Diseases.

Device Description

Invacare Venture Home Fill Complete Oxygen System

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "Invacare Model IHO 100 Home Fill Complete Home Oxygen System." This type of document declares substantial equivalence to a predicate device and permits marketing. It does not contain any information about acceptance criteria, device performance studies, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input. The document is strictly a regulatory clearance letter and does not delve into the technical details of the device's performance or the studies conducted to demonstrate it.

§ 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).