Vapotherm Precision Flow Receives FDA 510(k) Clearance

The FDA has given 510(k) clearance to Vapotherm for Precision Flow, the company’s high-flow humidification system to treat patients with respiratory disorders.

Designed for use in neonatal, pediatric and adult applications, the system provides noninvasive respiratory assistance.

The system integrates gas blending, flow control and humidification technology into one device for the conditioning of nasal cannula-inspired gases, Vapotherm said.