The following data is part of a premarket notification filed by Bio-scan, Inc. with the FDA for Eeg Analyzer.
| Device ID | K925735 |
| 510k Number | K925735 |
| Device Name: | EEG ANALYZER |
| Classification | Analyzer, Spectrum, Electroencephalogram Signal |
| Applicant | BIO-SCAN, INC. 3200 PLEASANT RUN RD. STE. 105 Lancaster, TX 75146 |
| Contact | Ronald K Weber |
| Correspondent | Ronald K Weber BIO-SCAN, INC. 3200 PLEASANT RUN RD. STE. 105 Lancaster, TX 75146 |
| Product Code | GWS |
| CFR Regulation Number | 882.1420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-13 |
| Decision Date | 1993-12-03 |