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The following FDA Disclaimer is required for all eBay listing in Healthcare category and is included for REFERENCE: 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 the item is subject to FDA regulation, we will verify your status as an authorized purchaser of this item before shipping of the item.

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