ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)— 510(k) K252360
Substantially EquivalentAnumana, Inc.
FDA 510(k) clearance K252360 for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020), Substantially Equivalent on 2026-03-28. Applicant: Anumana, Inc.. Device class: 2.
Clearance details
- Applicant
- Anumana, Inc.
- Product code
- Code SAT
- Device class
- Class 2
- Regulation
- 21 CFR 870.2380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
Recent devices under product code SAT
view allMore clearances from Anumana, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.