Portable ventilator, electric [47083]: Trilogy Evo, O2, International – Model IN2100X15B (Extension of Suspension from the ARTG under s. 41GC(3))
Product name
Portable ventilator, electric [47083]: Trilogy Evo, O2, International – Model IN2100X15B
Date action takes effect
Compliance action
Medical device suspension
Type of action
Extension of Suspension from the ARTG under paragraph 41GC(3) of the Act
Grounds for regulatory action
Under paragraph 41GC(3); the sponsor has demonstrated that steps have been taken to remove the grounds for cancelling the entry of the kind of device from the Register under section 41GN and hence extend the period specified in the notice under subsection 41GA(1) by a further specified period not exceeding 6 months.
This applies to the specified models tabled below, not the entire ARTG entry. The suspension has been extended to the period from 31 October 2023 to 30 April 2024.
ARTG ID
ARTG Name
Model
Description
332200
‘Portable ventilator, electric’
IN2100X15B
Trilogy Evo, O2, International
336800
‘Portable ventilator, electric’
IN2200X15B
Trilogy EV300, INTL