510(k) K252360
- Device
- ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
- Applicant
- Anumana, Inc.
- 510(k) number
- K252360
- Product code
- SAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-28
- Date received
- 2025-07-29
- Regulation
- 870.2380
- Classification name
- Pulmonary Hypertension Machine Learning-Based Notification Software
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Taylor Gold West
- Address
- One Main St., Suite 400 East Arcade 4th Floor Cambridge MA US 02142 02142
FDA Registration Numbers#
- 3033300766
Source Documents#
Other 510(k) Records For Product Code SAT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233666 | CorVista System with PH Add-On | Analytics For Life, Inc. | 2024-04-05 |