IS THE SALE OF FINGERTIP PULSE OXIMETRY EQUIPMENT subject to FDA regulation.?
…e.g., is it allowable to sell a fingertip pulse oximeter on ebay (I happen to have a new one in th box I dont use nor foresee using) or is this regulated and required to have a licensure or certification of sorts? I dont wish to list this and find I’m in violation of anything…. thnx in advance
One seller puts it this way:
“The Fingertip Pulse Oximeter is registered on the Australian Register of Therapeutic Goods(ARTG) with the code 135574 and certified by FDA of United States FDA510K No. K070371 and CE, TUV of Europe.
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 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”
For more info: http://www.google.com/search?hl=en&rls=ig&num=100&newwindow=1&q=SALE+OF+FINGERTIP+PULSE+OXIMETRY+EQUIPMENT+subject+to+FDA+regulation&btnG=Search
Pulse Oximeter Fingertip PC-60C
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