510(k) K100402 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SITE-RITE VISION ULTRASOUND SYSTEM
| Applicant | Bard Access Systems, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Mar 5, 2010 |
| Received | Feb 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100402
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2011 | Bard Access Systems Site Rite Vision Ultrasound System, REF 9770032,
Bard Access Systems, Inc.
Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.