HEI
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Monitor, Heart-Valve Movement, Fetal, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DRG REACTION CHAMBER/SAFETY TIP (K012003) | Doctor'S Research Group, Inc. | 2002-02-12 |
| SNOWDEN-PENCER IRRIGATION PUMP (K920985) | Snowden-Pencer | 1992-06-09 |
| INNERVISION IRRIGATION PUMP (K910982) | M.D. Engineering, Inc. | 1991-08-26 |
Track HEI automatically
Every clearance here is in the API, with alerts when new ones post.