We'll do our best to help you. The Fingertip Pulse-Oximeter is registered on the Australian Register of Therapeutic Goods (ARTG) with the code 136606, and certified by FDA of United States Premarket Submission Number (510K): K073454 Listing Number: D045684, K082641 Listing Number: D064765, K090671 Listing Number: D078664; and CE Approved, TUV of Europe Cert. G1 10 02 50972 013.
You can consult with the FDA's Center for Devices and Radiological Health. This item is in the category "Business & Industrial\Healthcare, Lab & Dental\Other Healthcare, Lab & Dental". The seller is "medicalshop888" and is located in this country: US. This item can be shipped to United States.