Would I include the components of a HLM as generic or list them as different systems that can be customized and configured to a central monitoring systems if the components don't have 510K clearance as individual systems? Or will they need individual 510k clearance first before it can be a part of the Perfusion System? Plus the Perfusion system can be use by other manufactures centrifugal pumps with the system...vendor neutrality.
e.g. Ventilation system is a monitoring system that will monitor and adjust to settings and is an accessory to the Perfusion system?
I did a look up roller blood pumps, ventilation, and blood gas monitors and Perfusion Systems. They all seem to have their own 510k clearances.
Any discussion on the subject would be appreciated.
e.g. Ventilation system is a monitoring system that will monitor and adjust to settings and is an accessory to the Perfusion system?
I did a look up roller blood pumps, ventilation, and blood gas monitors and Perfusion Systems. They all seem to have their own 510k clearances.
Any discussion on the subject would be appreciated.
