FDA Product Code QZA: Body Temperature Sensing Software
Body Temperature Sensing Software Is A Software Device Used For The Determination Of Human Body Temperature By Means Of Analyzing Input Sensor Data.
Leading manufacturers include Fitbit, LLC.
FDA 510(k) Cleared Body Temperature Sensing Software Devices (Product Code QZA)
About Product Code QZA - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QZA since 2023, with 1 receiving FDA clearance (average review time: 109 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 QZA have taken an average of 66 days to reach a decision - down from 151 days historically, suggesting improved FDA processing for this classification.
QZA devices are reviewed by the General Hospital panel. Browse all General Hospital devices →