The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Ceregrotrac.
| Device ID | K842784 |
| 510k Number | K842784 |
| Device Name: | CEREGROTRAC |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | ADVANCED INSTRUMENTS, INC. SHORASHIM |
| Contact | Phyllis Bellin |
| Correspondent | Phyllis Bellin ADVANCED INSTRUMENTS, INC. SHORASHIM |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-17 |
| Decision Date | 1985-01-10 |