FDA Product Code SFR: Hypertension Machine Learning-based Notification Software
Hypertension Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Hypertension For Further Referral Or Diagnostic Follow-up.
Leading manufacturers include Apple, Inc..
1
Total
1
Cleared
202d
Avg days
2025
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Hypertension Machine Learning-based Notification Software Devices (Product Code SFR)
1 devices
About Product Code SFR - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SFR since 2025, with 1 receiving FDA clearance (average review time: 202 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.