Panels › Obstetrics/Gynecology › Product code HEL · Class 2
Monitor, Heart Rate, Fetal, Ultrasonic
Regulation 884.2660
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HEL
| Company | 510(k)s | Recalls |
|---|---|---|
| Oxford Instruments, Plc. | 2 | 0 |
| Alexander Mfg. Co. | 1 | 0 |
| Card Guard Scientific Survival , Ltd. | 1 | 0 |
| Corometrics Medical Systems, Inc. | 1 | 0 |
| Medical Cables, Inc. | 1 | 0 |
| Metrix Teknika, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 9, 2001 | K003876 | US SENSOR #CG-930P; TOCO SENSOR CG-940P Card Guard Scientific Survival , Ltd., IL | HEL |
| Jun 22, 2001 | K010920 | TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING Medical Cables, Inc. | HEL |
| Dec 11, 1998 | K982651 | COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER Corometrics Medical Systems, Inc. | HEL |
| Jun 6, 1997 | K971240 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 Alexander Mfg. Co. | HEL |
| Aug 24, 1995 | K930714 | SONICAID MODEL TEAM FECG IUP Oxford Instruments, Plc. | HEL |
| Dec 22, 1994 | K933816 | SONICAID MODEL P110 FETAL HEAR DETECTOR Oxford Instruments, Plc. | HEL |
| Mar 6, 1978 | K780035 | MINIVISOR Metrix Teknika, Inc. | HEL |
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