Manual-inflation electronic sphygmomanometer, portable (Cancelled from the ARTG under s.41GN(1)(b))
Product name
Manual-inflation electronic sphygmomanometer, portable
Sponsor
ARTG
204514
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s.41GN(1)(b)
Grounds for regulatory action
As the sponsor did not provide sufficient information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition of inclusion to which the kind of device in the ARTG was subject under s.41FN(3)(a) and (3)(c).