510(k) K041688 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jul 8, 2004 |
| Received | Jun 22, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041688
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2006 | General Electric Med. Sys. Ultrasound Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.