Biofeedback system [10396] (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
Biofeedback system [10396]
Sponsor
ARTG
200795
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsection 41GN(1) of the Act
Grounds for regulatory action
The sponsor failed to provide evidence to demonstrate that the medical device complies with the applicable provisions of the Essential Principles. The sponsor therefore failed to comply with an automatic condition of inclusion (s41FN(3)(a) of the Act).