FDA Product Code BZH: Meter, Peak Flow, Spirometry
Leading manufacturers include Gostar Co., Ltd., Taian Dalu Medical Instrument Co., Ltd. and Knox Medical Diagnostics.
FDA 510(k) Cleared Meter, Peak Flow, Spirometry Devices (Product Code BZH)
About Product Code BZH - Regulatory Context
510(k) Submission Activity
79 total 510(k) submissions under product code BZH since 1977, with 79 receiving FDA clearance (average review time: 204 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under BZH have taken an average of 345 days to reach a decision - up from 200 days historically. Manufacturers should account for longer review timelines in current project planning.
BZH devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →