510(k) K060421 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONARA; SONARA/TEK
| Applicant | Viasys Healthcare, Inc., Conshohocken PA, US |
| Decision | Substantially Equivalent, Nov 3, 2006 |
| Received | Feb 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060421
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2009 | Cardinal Health, Inc Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral.
The Sonara Transcranial Doppler system is a medical ultrasound device for Terminated |
IYN | None listed |
| Apr 7, 2009 | Cardinal Health, Inc Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0470 Sonara Bilateral.
The Sonara Transcranial Doppler system is a medical ultrasound device for n Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.