510(k) K030357 ยท DPW Flowmeter, Blood, Cardiovascular
QUANTIX/OR DEVICE
| Applicant | Cardiosonix, Ltd., Kfar Saba, IL |
| Decision | Substantially Equivalent, Aug 20, 2003 |
| Received | Feb 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2005 | Neoprobe Corp Product is CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system. Terminated |
DPW | None listed |
| Apr 13, 2005 | Neoprobe Corp Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system. Terminated |
DPW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.