From the December Quarterly released 31 January 2022
The final steps towards lodging the CONNEQT Pulse & App for FDA 501(k) clearance are being
undertaken, with technical and product development work now complete and regulatory
documentation in the final stages of completion. The FDA lodgement, via our manufacturing partner
Andon, is expected shortly in the current quarter.
Has the FDA lodgement already happened without an announcement or are we still waiting on lodgement?
If still waiting on the lodgement would seem unusual as it seemed only regulatory documentation only needed to be done as of Jan 31.
From the December Quarterly released 31 January 2022 The final...
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