510(k) K250851 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Hypnos (369054-200)
| Applicant | Cadwell Industries, Inc., Kennewick WA, US |
| Decision | Substantially Equivalent, Dec 14, 2025 |
| Received | Mar 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250851
No recall in the FDA data names this 510(k).
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