HEL
7 FDA 510(k) clearances · Product code
134 daysmedian time to decision
924 days90th percentile
7clearances measured
FDA profile
- Official device name
- Monitor, Heart Rate, Fetal, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 2 · 1997: 1 · 1998: 4 · 1999: 1 · 2002: 1
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 |
|---|---|---|
| US SENSOR #CG-930P; TOCO SENSOR CG-940P (K003876) | Card Guard Scientific Survival , Ltd. | 2001-07-09 |
| TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING (K010920) | Medical Cables, Inc. | 2001-06-22 |
| COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER (K982651) | Corometrics Medical Systems, Inc. | 1998-12-11 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 (K971240) | Alexander Mfg. Co. | 1997-06-06 |
| SONICAID MODEL TEAM FECG IUP (K930714) | Oxford Instruments, Plc. | 1995-08-24 |
| SONICAID MODEL P110 FETAL HEAR DETECTOR (K933816) | Oxford Instruments, Plc. | 1994-12-22 |
| MINIVISOR (K780035) | Metrix Teknika, Inc. | 1978-03-06 |
Track HEL automatically
Every clearance here is in the API, with alerts when new ones post.