FDA Product Code BZG: Spirometer, Diagnostic
Leading manufacturers include Feellife Health, Inc., Roundworks Technologies Private Limited and Ndd Medizintechnik AG.
FDA 510(k) Cleared Spirometer, Diagnostic Devices (Product Code BZG)
About Product Code BZG - Regulatory Context
510(k) Submission Activity
228 total 510(k) submissions under product code BZG since 1977, with 228 receiving FDA clearance (average review time: 165 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 7 in the prior period.
FDA Review Time
Recent submissions under BZG have taken an average of 206 days to reach a decision - up from 164 days historically. Manufacturers should account for longer review timelines in current project planning.
BZG devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →