510(k) K150691 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Datalys Multi-Parameter Patient Monitor
| Applicant | Lutech Industries, Inc., Ronkonkoma NY, US |
| Decision | Substantially Equivalent, May 15, 2015 |
| Received | Mar 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150691
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.