510(k) K261521 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Sleep Analysis Module
| Applicant | Neurotronics, LLC, Alachua FL, US |
| Decision | Substantially Equivalent, Oct 9, 2026 |
| Received | May 7, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261521
No recall in the FDA data names this 510(k).
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