510(k) K043189 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SONALIS, MODEL 2000
| Applicant | 3g Ultrasound, Inc., Boynton Beach FL, US |
| Decision | Substantially Equivalent, Feb 9, 2005 |
| Received | Nov 17, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K043189
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.