The following data is part of a premarket notification filed by Applied Neuroscience Inc. with the FDA for Neuroguide Analysis System.
| Device ID | K041263 |
| 510k Number | K041263 |
| Device Name: | NEUROGUIDE ANALYSIS SYSTEM |
| Classification | Normalizing Quantitative Electroencephalograph Software |
| Applicant | APPLIED NEUROSCIENCE INC. 228 176TH TERRACE DRIVE St. Petersburg, FL 33708 |
| Contact | Robert W Thatcher |
| Correspondent | Robert W Thatcher APPLIED NEUROSCIENCE INC. 228 176TH TERRACE DRIVE St. Petersburg, FL 33708 |
| Product Code | OLU |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-11 |
| Decision Date | 2004-08-03 |
| Summary: | summary |