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Alias Born 02/09/2022

Re: None

Monday, 06/06/2022 9:48:04 AM

Monday, June 06, 2022 9:48:04 AM

Post# of 31325
yea that'll be game set and match for now, back to the drawing board and back to baseline to draft this new 510k. no clue how they define a CPAP machine as an implantable device and recommend they go down that route? i work for an implantable monitoring device company for cardiology, similar to a pacemaker, and that is the 510k process we used. odd direction from the FDA. either way.....lost a little here...using the rest towards TCRI which could be massive.....
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