The following data is part of a premarket notification filed by Ambulatory Monitoring, Inc. with the FDA for Actillume.
| Device ID | K894044 |
| 510k Number | K894044 |
| Device Name: | ACTILLUME |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | AMBULATORY MONITORING, INC. 731 SAW MILL RIVER RD. Ardsley, NY 10502 |
| Contact | William Gruen |
| Correspondent | William Gruen AMBULATORY MONITORING, INC. 731 SAW MILL RIVER RD. Ardsley, NY 10502 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-07 |
| Decision Date | 1989-12-22 |