510(k) K011365 ยท DQA Oximeter
VITALSAT PULSE OXIMETER, MODEL IC32000
| Applicant | Island Critical Care Corp., Stratford, P.E.I., CA |
| Decision | Substantially Equivalent, Oct 26, 2001 |
| Received | May 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011365
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.