Panels › Obstetrics/Gynecology › Product code MAA · Class 2
Monitor, Fetal Doppler Ultrasound
Regulation 884.2660
0510(k)s in 12 months (9 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in MAA
| Company | 510(k)s | Recalls |
|---|---|---|
| Acuson Corp. | 3 | 0 |
| Siemens Medical Solutions USA, Inc. | 0 | 2 |
| Danatech Medical Systems Inc | 0 | 1 |
| Edan Instruments, Inc. | 1 | 0 |
| GE Medical Systems | 1 | 0 |
| Oxford Medilog, Inc. | 1 | 0 |
| Quantum Medical Systems, Inc. | 1 | 0 |
| Summit Doppler Systems, Inc. | 1 | 0 |
| Toshiba America Medical Systems, In.C | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 28, 2010 | K102138 | ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER Edan Instruments, Inc., CN | MAA |
| Mar 31, 2009 | K090499 | LIFEDOP MODEL, L350R Summit Doppler Systems, Inc. | MAA |
| Oct 20, 1992 | K915138 | GE SONOCHROME GE Medical Systems | MAA |
| Apr 21, 1992 | K905536 | FETAL DOPPLER Toshiba America Medical Systems, In.C | MAA |
| Jun 24, 1991 | K904600 | L582 TRANSDUCER Acuson Corp. | MAA |
| May 28, 1991 | K905456 | L328 TRANSDUCER Acuson Corp. | MAA |
| Apr 29, 1991 | K904951 | S5192R TRANSDUCER Acuson Corp. | MAA |
| Jul 9, 1990 | K895909 | SONICAID MODEL VASOFLO 4 Oxford Medilog, Inc. | MAA |
| Feb 23, 1990 | K894992 | QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM Quantum Medical Systems, Inc. | MAA |
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