510(k) K994096 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM
| Applicant | Sonosite,Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Dec 20, 1999 |
| Received | Dec 3, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994096
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.