IYY
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Synchronizer, Electrocardiograph, Nuclear
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.1410
- Medical specialty
- Radiology
- Adverse events (MAUDE)
- 1999: 4 · 2000: 1 · 2005: 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 |
|---|---|---|
| VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) (K853737) | Capintec, Inc. | 1986-02-13 |
| GENERATOR, R-WAVE (K790213) | Amr Co. | 1979-03-22 |
| NUCLEAR STETHOSCOPE (K780510) | Bios, Inc. | 1978-04-18 |
Track IYY automatically
Every clearance here is in the API, with alerts when new ones post.