CorVista System with PH Add-On
FDA 510(k) clearance K233666 · decided 2024-04-05
Clearance details
- K-number
- K233666
- Device name
- CorVista System with PH Add-On
- Applicant
- Analytics For Life, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-15
- Decision date
- 2024-04-05
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- SAT
- Device class
- 2
- Regulation number
- 870.2380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (K252360) | Anumana, Inc. | 2026-03-28 |
Recalls involving this device
No recalls on record reference this clearance.