Pure Global AI
FDA product code SAT

Pulmonary Hypertension Machine Learning-Based Notification Software

CardiovascularClass 221 CFR 870.2380
Verified
US regulatory classifications
US Product Code (FDA)
SAT
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.2380
View CFR Regulation
Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up.

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About this record

Pulmonary Hypertension Machine Learning-Based Notification Software is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.