The following data is part of a premarket notification filed by Natus Neurology Incorporated with the FDA for Nicoletone.
| Device ID | K173366 |
| 510k Number | K173366 |
| Device Name: | NicoletOne |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | Natus Neurology Incorporated 3150 Pleasant View Road Middleteon, WI 53562 |
| Contact | Shane T. Sawall |
| Correspondent | Martin A Dockter Natus Neurology Incorporated 3150 Pleasant View Road Middleton, WI 53562 |
| Product Code | OLZ |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMA |
| Subsequent Product Code | OMB |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-26 |
| Decision Date | 2018-07-20 |
| Summary: | summary |