(INVESTIGATIONAL DEVICE, LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE):  The Medical Device is not cleared by the FDA for commercial distribution in the United States.  Therefore, it is NOT AVAILABLE FOR COMMERCIAL SALE.  The purpose of this statement is only to notify investigators and not to make the device generally available.

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease