Replies to post #42477 on Medizone Intl. (fka MZEIQ)

[Eli's Gone]

Here is what Ed said re: FDA approval from the 2013 10-K:

http://www.medizoneint.com/wp-content/uploads/medizone10k123113.pdf



the classification:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=2534

the requirements for Class I exempt devices (links at the bottom):

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm

Cogmedix FDA establishment registration can be found here:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

IMO the Asepticsure device listing should appear there as well