FDA Product Code
FDA Product Code HEL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2660
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K003876 | US SENSOR #CG-930P; TOCO SENSOR CG-940P | Card Guard Scientific Survival , Ltd. | 2001-07-09 | Traditional | PDF ↗ |
| K010920 | TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING | Medical Cables, Inc. | 2001-06-22 | Traditional | PDF ↗ |
| K982651 | COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER | Corometrics Medical Systems, Inc. | 1998-12-11 | Traditional | PDF ↗ |
| K971240 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 | Alexander Mfg. Co. | 1997-06-06 | Traditional | PDF ↗ |
| K930714 | SONICAID MODEL TEAM FECG IUP | Oxford Instruments, Plc. | 1995-08-24 | Traditional | PDF ↗ |
| K933816 | SONICAID MODEL P110 FETAL HEAR DETECTOR | Oxford Instruments, Plc. | 1994-12-22 | Traditional | PDF ↗ |
| K780035 | MINIVISOR | Metrix Teknika, Inc. | 1978-03-06 | Traditional | PDF ↗ |
Product code HEL · Class II · Obstetrics/Gynecology. Data: openFDA.