LogoFDA 510(k) Search
K Number
K003939
Device Name
VENTURE HOME FILL II, MODEL IOH 200
Manufacturer
INVACARE CORP.
Date Cleared
2001-03-21

(90 days)

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

§ 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).