HEK · Monitor, Heart Sound, Fetal, Ultrasonic
Obstetrics/Gynecology · 21 CFR 884.2660 · Class 2
Overview
| Product Code | HEK |
|---|---|
| Device Name | Monitor, Heart Sound, 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142769 | Fetal Doppler | Icare Newlife Technologies, Inc. | Mar 20, 2015 | SESE |
| K060410 | ECHOHEART TRANSVAGINAL DOPPLER PROBE | Summit Doppler Systems, Inc. | Apr 10, 2006 | SESE |
| K902190 | FETAL PULSE DETECTOR MODEL DOP-1 | Advanced Medical Systems, Inc. | Oct 22, 1990 | SESE |
| K883334 | BIODOP(TM) | Diagnosis Related Systems, Inc. | Dec 15, 1988 | SESE |
| K771211 | DOPPLER (UTD-5 & UTD-6) | Terumo America, Inc. | Jul 14, 1977 | SESE |
Top Applicants
- Advanced Medical Systems, Inc. — 1 clearance
- Diagnosis Related Systems, Inc. — 1 clearance
- Icare Newlife Technologies, Inc. — 1 clearance
- Summit Doppler Systems, Inc. — 1 clearance
- Terumo America, Inc. — 1 clearance
