indicative, conditional, non-binding proposal , page-28

Nurse call systems in the USA are subject to FDA Part 510k.
They must be classified before being legally allowed to be sold. If the nurse call system is connected to critical infrastructure it must be FDA approved. Austco Tacera is seeking to be FDA approved but this may cost a fortune and may take forever.

It has nothing to do with EMC pre compliance, radiated emissions or Ul1069 industry certification.

If your writing software that will be used in the USA and passes critical information from medical diagnostic equipment or exchanges medical information then you will need FDA certification as well.