FDA Product Code QDB: Photoplethysmograph Analysis Software For Over-the-counter Use
A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Irregular Heart Rhythms. This Device Is Not Intended To Provide A Diagnosis.
Leading manufacturers include Apple, Inc. and Fitbit, Inc..
FDA 510(k) Cleared Photoplethysmograph Analysis Software For Over-the-counter Use Devices (Product Code QDB)
About Product Code QDB - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QDB since 2018, with 4 receiving FDA clearance (average review time: 122 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
QDB devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →