FDA Product Code
FDA Product Code SDJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2200
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250151 | Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2025-06-20 | Traditional | PDF ↗ |
| K243866 | InVision Precision Cardiac Amyloid | InVision Medical Technology Corporation | 2025-05-21 | Traditional | PDF ↗ |
| K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | 2024-11-15 | Traditional | PDF ↗ |
Product code SDJ · Class II · Cardiovascular. Data: openFDA.