510(k) K971628 ยท DQA Oximeter
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
| Applicant | Somanetics Corp., Troy MI, US |
| Decision | Substantially Equivalent, Oct 10, 1997 |
| Received | May 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971628
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.