510(k) K103168 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Jan 6, 2011 |
| Received | Oct 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103168
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.