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SFRClass II

Hypertension Machine Learning-Based Notification Software

21 CFR 870.2380 / Cardiovascular
FDA source (opens on fda.gov)

SFR is the FDA product code for Hypertension Machine Learning-Based Notification Software, a class II device type, regulated under 21 CFR 870.2380. FDA's definition for this code reads: "Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SFR
Device name
Hypertension Machine Learning-Based Notification Software
FDA definition
Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up.
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SFR

By decision year
1 clearance under product code SFR with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SFR by decision year
YearClearances
20251

Applicants with the most clearances

Product code SFR
Applicants holding the most 510(k) clearances under product code SFR
ApplicantClearances
Apple Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code