ApnoSystems is a wearable device that intends to prevent premature babies at home monitoring from critical situations, such as hypoxia and/or bradycardia. NCC-PDI is continuously supporting ApnoSystems in the areas of regulatory and clinical expertise.
Year:
2017
Anticipated Classification:
Class II
Anticipated Regulatory Path:
510(k)
Initial Development Stage:
Prototyping
Current Development Stage:
Prototyping
