The following data is part of a premarket notification filed by Ice Neurosystems, Inc. with the FDA for Icewav Neuromonitoring Platform.
| Device ID | K191868 |
| 510k Number | K191868 |
| Device Name: | ICEWav Neuromonitoring Platform |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | iCE Neurosystems, Inc. 1875 Connecticut Ave NW, Suite 12117 Washington, DC 20007 |
| Contact | Allen Waziri |
| Correspondent | Allison Komiyama EAS Consulting Group, LLC 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-12 |
| Decision Date | 2020-03-31 |
| Summary: | summary |