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pepeoil

04/07/20 8:14 AM

#133595 RE: captbob2112 #133594

Ten 4 there good buddy. It appears those were just that, old cases sitting in a warehouse, that were dusted off for a photo. Did you see roll of paper towels? Lol. Are they fda approved?
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toncatmad

04/07/20 9:06 AM

#133600 RE: captbob2112 #133594

You gotta look into the FDA info. I started to look at it last night.
The original owners acquired a 510(k) back in 1995. A 510(k) is not tested or anything by the FDA. The original owners only had to prove that the RX3000 was substantially like another already approved air purifier.
The stricter one us the PMA which requires clinical trials.
The Rx4500 and 9000 do not have any FDA paperwork along with them.
The link talks about the 510(k) process

https://www.drugwatch.com/fda/510k-clearance/