HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2

• K Number: K991569
• Device Name: HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
• Manufacturer: 02 MARKETING GROUP, INC.
• Date Cleared: 1999-08-03 ( 90 days)
• Product Code: CAW
• Regulation Number: 868.5440
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Home/Commercial Oxygen Unit by system O2™ is intended to provide oxygen for emergency first aid.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the "Home/Commercial Oxygen Unit by System O2™". The document is an FDA 510(k) clearance letter, which primarily addresses the substantial equivalence of the device to a legally marketed predicate device.

The information you are requesting, such as specific performance metrics, study details, and ground truth establishment, is not present in this regulatory document.

Regulation Number and Section

§ 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).