Ventilation | 合法醫療器材資訊網

Philipshomeventilatorsaredesignedtoaddressrespiratoryconditionswithinvasiveandnoninvasivetherapyinsimpleandeasytousesolutionsforthehome ...

1 Philips V60 Plus ventilator software upgrade is provided in the US under an FDA emergency use policya, which authorizes its use for the duration of the COVID-19 public health emergency declaration, after which the software upgrade may no longer be used. This device is not FDA cleared or approved.

a Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, issued March 2020

2 The Philips Respironics E30 Ventilator is provided globally for use under local emergency use authorizations, such as the FDA Emergency Use Authorization for ventilators, Health Canada Interim Order for use in relation to COVID-19, and waiver of CE marking, which authorize its use for the duration of the COVID-19 public health emergency, unless terminated or revoked (after which...