The following data is part of a premarket notification filed by Neurotronics, Inc. with the FDA for Polysmith Sleep System, Model Nti7593.
| Device ID | K161650 |
| 510k Number | K161650 |
| Device Name: | Polysmith Sleep System, Model NTI7593 |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | Neurotronics, Inc. 3600 NW 43rd Street, STE F1 Gainesville, FL 32606 |
| Contact | David Pezet |
| Correspondent | David Pezet Neurotronics, Inc. 3600 NW 43rd Street, STE F1 Gainesville, FL 32606 |
| Product Code | OLV |
| Subsequent Product Code | DQA |
| Subsequent Product Code | MLO |
| Subsequent Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-15 |
| Decision Date | 2017-01-19 |
| Summary: | summary |