510(k) K171397 ยท GWL Amplifier, Physiological Signal
Sienna Ultimate Wireless Amplifier
| Applicant | Ems Handels Gesellschaft M.B.H., Korneuburg, AT |
| Decision | Substantially Equivalent, Oct 6, 2017 |
| Received | May 11, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171397
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.