The following data is part of a premarket notification filed by Bio-scan, Inc. with the FDA for Bio-log 8+1 Ambulatory Physiologic Recorder.
| Device ID | K864928 |
| 510k Number | K864928 |
| Device Name: | BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | BIO-SCAN, INC. 1717 S. ERVAY ST. Dallas, TX 75215 |
| Contact | Larry S Gantt |
| Correspondent | Larry S Gantt BIO-SCAN, INC. 1717 S. ERVAY ST. Dallas, TX 75215 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-16 |
| Decision Date | 1987-03-31 |