510(k) K912045 ยท DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
| Applicant | Lifestream Int'L, Inc., The Woodlands TX, US |
| Decision | Substantially Equivalent, Oct 31, 1991 |
| Received | May 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912045
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.