It’s all there, as posted previously!
The links as per device classification:
I was interested to look at Third party Review (which CDX didn’t do). It’s a voluntary & alternative pathway of review, link here for people interested:
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/510k-third-party-review-program
@Dr Monopoly yes! Looks like a melded address between the manufacturer in China (Needed for ISO Certification with manufacture) & CDX Sydney address! I’m wondering if there were not 2 addresses in the application & not enough fields in the FDA publication & this is why? They have also gone through a Consultancy Company which is probably a very wise choice - The typos though lol! Maybe just my OCD, not letting that spoil a Good Thing! There is always something to be critical of, but I’m happy to wait until Wednesday now for news. All looking positive. At least up early & got this stuff read & done B4 Dawn Service at 6am. Have a Good ANZAC Day everyone.
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