510(k) K002957 ยท DQA Oximeter
SOLAR SPO2 MODULE WITH MASIMO SET
| Applicant | General Electric Medical Systems Information Techn, Milwaukee WI, US |
| Decision | Substantially Equivalent, Oct 18, 2000 |
| Received | Sep 22, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002957
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.