The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Bio-logic Ceegraph 128-channel Recording System.
| Device ID | K973883 |
| 510k Number | K973883 |
| Device Name: | BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Contact | Norman E Brunner |
| Correspondent | Norman E Brunner BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-14 |
| Decision Date | 1998-03-05 |
| Summary: | summary |