Food and Drug Administration and state and local regulatory agencies. If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA's Center for Devices and Radiological Health.
The Fingertip Pulse Oximeter is registered on the Australian Register of Therapeutic Goods (ARTG) with the code 197923, and certified by FDA of United States and CE, TUV of Europe. The Fingertip Pulse Oximeter that is FDA 510K Approved. Feel free to contact me at any time. This item is in the category "Business & Industrial\Healthcare, Lab & Dental\Medical & Lab Equipment, Devices\Ultrasound Machines". The seller is "medicalcare4u" and is located in this country: CN.This item can be shipped to North, South, or Latin America, all countries in Europe, all countries in continental Asia, Australia.