"The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item."
“According to U.S. federal regulations (21 CFR 892.1570, Product Code ITX), the ultrasound transducers are classified as a Class II medical device and enjoys FDA 510(k) clearance.,' U.S. law does not require a physician’s prescription for sale or purchase of the probe—only proper device registration and FDA clearance are needed.”
Bailey Brown
SUREVIEW MEDICAL IMAGING
+14802948596
Mesa, AZ