510(k) K062943 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
POLYSMITH SLEEP SYSTEM, MODEL NTI5498
| Applicant | Neurotronics, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, May 9, 2007 |
| Received | Sep 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062943
No recall in the FDA data names this 510(k).
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