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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Danatech Medical Systems Inc Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models. Terminated |
MAA | None listed |
| May 22, 2003 | Siemens Medical Solutions USA, Inc. Acuson Diagnostic Ultrasound System Transducer;
Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System;
Catalog Numbers: 23656 (New), 45441 (Refurb) Terminated |
MAA | K884632 |
| May 22, 2003 | Siemens Medical Solutions USA, Inc. Acuson Diagnostic Ultrasound System Transducer;
Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System;
Catalog Numbers: 23656 (New), 45441 (Refurb) Terminated |
MAA | K884632 |
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