510(k) K111055 ยท OLV Standard Polysomnograph With Electroencephalograph
GALAXY SYSTEM; JUPITER
| Applicant | Personal Health Institute International, Battle Creek MI, US |
| Decision | Substantially Equivalent, Dec 21, 2011 |
| Received | Apr 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111055
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.