The following data is part of a premarket notification filed by Bio-scan, Inc. with the FDA for Q.p. Preamplifier Sys.
| Device ID | K841683 |
| 510k Number | K841683 |
| Device Name: | Q.P. PREAMPLIFIER SYS |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | BIO-SCAN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-23 |
| Decision Date | 1984-06-07 |