KXN
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Monitor, Cardiac, Fetal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2600
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1997: 3 · 1998: 2 · 1999: 1 · 2000: 2 · 2001: 3 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ABDOMINAL FETAL ECG MODULE (K770245) | Mennen Greatbatch Electonics | 1977-02-14 |
| CENTRAL STATION REPEATER (MODEL 8032A) (K760968) | Hewlett-Packard Co. | 1976-12-17 |
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Every clearance here is in the API, with alerts when new ones post.