510(k) K011320 ยท DQA Oximeter
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Aug 9, 2001 |
| Received | May 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011320
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.