DRI
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Monitor, Line Isolation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.2620
- Medical specialty
- Cardiovascular
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR (K902493) | Datex Division Instrumentarium Corp. | 1990-07-06 |
| CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S (K902492) | Datex Division Instrumentarium Corp. | 1990-07-06 |
| HEART MONITOR BRACELET ALARM (K822316) | Hmba | 1982-09-21 |
| PRESSURE MONITORING LINES (K802326) | Stanco Medical, Inc. | 1980-10-10 |
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Every clearance here is in the API, with alerts when new ones post.