510(k) K233666
- Device
- CorVista System with PH Add-On
- Applicant
- Analytics For Life, Inc.
- 510(k) number
- K233666
- Product code
- SAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-05
- Date received
- 2023-11-15
- 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
- Gabrielle Zaeska
- Address
- 160 Bloor St. E. Suite 910 Toronto CA M4W 1B9 M4W 1B9
FDA Registration Numbers#
- 3033300766
Source Documents#
Other 510(k) Records For Product Code SAT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | 2026-03-28 |