MAA
9 FDA 510(k) clearances · Product code
199 daysmedian time to decision
497 days90th percentile
9clearances measured
FDA profile
- Official device name
- Monitor, Fetal Doppler Ultrasound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER (K102138) | Edan Instruments, Inc. | 2010-10-28 |
| LIFEDOP MODEL, L350R (K090499) | Summit Doppler Systems, Inc. | 2009-03-31 |
| GE SONOCHROME (K915138) | GE Medical Systems | 1992-10-20 |
| FETAL DOPPLER (K905536) | Toshiba America Medical Systems, In.C | 1992-04-21 |
| L582 TRANSDUCER (K904600) | Acuson Corp. | 1991-06-24 |
| L328 TRANSDUCER (K905456) | Acuson Corp. | 1991-05-28 |
| S5192R TRANSDUCER (K904951) | Acuson Corp. | 1991-04-29 |
| SONICAID MODEL VASOFLO 4 (K895909) | Oxford Medilog, Inc. | 1990-07-09 |
| QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM (K894992) | Quantum Medical Systems, Inc. | 1990-02-23 |
Track MAA automatically
Every clearance here is in the API, with alerts when new ones post.