510(k) K022004 ยท DQO Catheter, Intravascular, Diagnostic
CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1
| Applicant | Biosensors International-USA, Newport Beach CA, US |
| Decision | Substantially Equivalent, Mar 12, 2003 |
| Received | Jun 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022004
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.