MAA · Monitor, Fetal Doppler Ultrasound
Obstetrics/Gynecology · 21 CFR 884.2660 · Class 2
Overview
| Product Code | MAA |
|---|---|
| Device Name | Monitor, Fetal Doppler Ultrasound |
| 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K102138 | ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER | Edan Instruments, Inc. | Oct 28, 2010 | SESE |
| K090499 | LIFEDOP MODEL, L350R | Summit Doppler Systems, Inc. | Mar 31, 2009 | SESE |
| K915138 | GE SONOCHROME | GE Medical Systems | Oct 20, 1992 | SESE |
| K905536 | FETAL DOPPLER | Toshiba America Medical Systems, In.C | Apr 21, 1992 | SESE |
| K904600 | L582 TRANSDUCER | Acuson Corp. | Jun 24, 1991 | SESE |
| K905456 | L328 TRANSDUCER | Acuson Corp. | May 28, 1991 | SESE |
| K904951 | S5192R TRANSDUCER | Acuson Corp. | Apr 29, 1991 | SESE |
| K895909 | SONICAID MODEL VASOFLO 4 | Oxford Medilog, Inc. | Jul 9, 1990 | SESE |
| K894992 | QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM | Quantum Medical Systems, Inc. | Feb 23, 1990 | SESE |
Top Applicants
- Acuson Corp. — 3 clearances
- Edan Instruments, Inc. — 1 clearance
- GE Medical Systems — 1 clearance
- Oxford Medilog, Inc. — 1 clearance
- Quantum Medical Systems, Inc. — 1 clearance
