NQYClass IILife-sustaining
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
Anesthesiology · 21 CFR 868.5895
This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.