Where is NIOX Flex approved for clinical use?
NIOX Flex is cleared with FDA for clinical use in the USA according to 510(k) K021133 and ETL-Classified according to General Requirements for Safety CAN/CSA-C22.2 No. 601.1 and UL-60601-1. NIOX Flex is also CE marked according to Medical Device Directive MDD 93/42/EEC and approved for clinical use in EEC countries.
Related Questions
- I participated in an MDCB approved activity prior to my clinical medical dosimetry experience. Can I apply the activity to the 12 CE credit eligibility requirement?
- What didactic courses and clinical training must be included in my approved training program?
- Are there any centers where NIOX Flex is used in clinical practice?
