FDA Clearance for bellavista 1000
At the beginning of August, imtmedical ag received 510 (k) clearance for the ventilator bellavista 1000 from the U.S. Food and Drug Administration (FDA). According to the regulations of FDA, bellavista 1000 is a class II medical device. In order to get the clearance, we went through a complex procedure, in which our device was examined in great detail. The clearance is a very big success for imtmedical: Now we are able to deliver our bellavista 1000 ventilators in a new market and can fulfil the requirements of other institutions worldwide, which require FDA approved ventilators.
bellavista 1000 is an innovative and highly reliable ICU-ventilator for invasive and non-invasive ventilation with a wide range of application possibilities that provide users with optimal solutions for their patients at any time. In addition to its high precision and the user-friendly handling via a 13.3” color touchscreen, bellavista ventilators convince through ventilation modes such as Continuous Positive Airway Pressure (CPAP), Pressure Controlled Ventilation (PCV) and Volume Assist Control Ventilation (V-A/C).
Published on August 2017 Back