Certification

 

FDA 
Ornim’s monitors, are cleared for marketing by the FDA for monitoring regional hemoglobin oxygen saturation of blood in the brain and in a region of skeletal muscle tissue of an adult.

 
Ornim’s oximeters carry CE Marking (CE₀₄₇₃), and conform to the provision of Annex II of Directive 93/42/EEC on medical devices. 

 
Ornim’s quality assurance system conforms to the requirements of ISO 13485:2003 for design, development manufacture and marketing of oximeters.