HEL · Monitor, Heart Rate, Fetal, Ultrasonic
Obstetrics/Gynecology · 21 CFR 884.2660 · Class 2
Overview
| Product Code | HEL |
|---|---|
| Device Name | Monitor, Heart Rate, Fetal, Ultrasonic |
| Regulation | 21 CFR 884.2660 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K003876 | US SENSOR #CG-930P; TOCO SENSOR CG-940P | Card Guard Scientific Survival , Ltd. | Jul 9, 2001 | SESE |
| K010920 | TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING | Medical Cables, Inc. | Jun 22, 2001 | SESE |
| K982651 | COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER | Corometrics Medical Systems, Inc. | Dec 11, 1998 | SESE |
| K971240 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 | Alexander Mfg. Co. | Jun 6, 1997 | SESE |
| K930714 | SONICAID MODEL TEAM FECG IUP | Oxford Instruments, Plc. | Aug 24, 1995 | SESE |
| K933816 | SONICAID MODEL P110 FETAL HEAR DETECTOR | Oxford Instruments, Plc. | Dec 22, 1994 | SESE |
| K780035 | MINIVISOR | Metrix Teknika, Inc. | Mar 6, 1978 | SESE |
Top Applicants
- Oxford Instruments, Plc. — 2 clearances
- Alexander Mfg. Co. — 1 clearance
- Card Guard Scientific Survival , Ltd. — 1 clearance
- Corometrics Medical Systems, Inc. — 1 clearance
- Medical Cables, Inc. — 1 clearance
