Monitor, Fetal Doppler Ultrasound
The Fetal Doppler Ultrasound Monitor (product code MAA) is a diagnostic device that uses Doppler ultrasound technology to continuously monitor and display the fetal heart rate during pregnancy or labor, providing real-time assessment of fetal well-being. Regulated under 21 CFR 884.2660 and classified as a Class 2 device, it requires a 510(k) premarket notification and is eligible for third-party review. The device falls under the Obstetrics/Gynecology specialty with review by the Radiology (RA) panel. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MAA
- Device Class
- FDA class 2
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K102138 | ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER | Oct 28, 2010 | Substantially Equivalent | Edan Instruments, Inc. |
| K090499 | LIFEDOP MODEL, L350R | Mar 31, 2009 | Substantially Equivalent | Summit Doppler Systems, Inc. |
| K915138 | GE SONOCHROME | Oct 20, 1992 | Substantially Equivalent | GE Medical Systems |
| K905536 | FETAL DOPPLER | Apr 21, 1992 | Substantially Equivalent | Toshiba America Medical Systems, In.C |
| K904600 | L582 TRANSDUCER | Jun 24, 1991 | Substantially Equivalent | Acuson Corp. |
| K905456 | L328 TRANSDUCER | May 28, 1991 | Substantially Equivalent | Acuson Corp. |
| K904951 | S5192R TRANSDUCER | Apr 29, 1991 | Substantially Equivalent | Acuson Corp. |
| K895909 | SONICAID MODEL VASOFLO 4 | Jul 09, 1990 | Substantially Equivalent | Oxford Medilog, Inc. |
| K894992 | QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM | Feb 23, 1990 | Substantially Equivalent | Quantum Medical Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.