FDA Product Code JEH: Plethysmograph, Volume
Leading manufacturers include Vitalograph (Ireland) , Ltd. and Ganshorn Medizin Electronic GmbH.
FDA 510(k) Cleared Plethysmograph, Volume Devices (Product Code JEH)
About Product Code JEH - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code JEH since 1985, with 11 receiving FDA clearance (average review time: 229 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under JEH have taken an average of 270 days to reach a decision - up from 225 days historically. Manufacturers should account for longer review timelines in current project planning.
JEH devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →