The following data is part of a premarket notification filed by Brainscope Company, Inc. with the FDA for Zoom-100dc.
| Device ID | K082886 |
| 510k Number | K082886 |
| Device Name: | ZOOM-100DC |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | BRAINSCOPE COMPANY, INC. 1717 RHODE ISLAND AVE. 9TH FLOOR Washington, DC 20036 |
| Contact | Michael E Singer |
| Correspondent | Michael E Singer BRAINSCOPE COMPANY, INC. 1717 RHODE ISLAND AVE. 9TH FLOOR Washington, DC 20036 |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2009-08-10 |
| Summary: | summary |