510(k) K001842 ยท DQA Oximeter
ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100
| Applicant | Somanetics Corp., Troy MI, US |
| Decision | Substantially Equivalent, Sep 15, 2000 |
| Received | Jun 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001842
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.