K894044 is an FDA 510(k) clearance for the ACTILLUME. This device is classified as a Full-montage Standard Electroencephalograph (Class II - Special Controls, product code GWQ).
Submitted by Ambulatory Monitoring, Inc. (Ardsley, US). The FDA issued a Cleared decision on December 22, 1989, 198 days after receiving the submission on June 7, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations.
| 510(k) Number | K894044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1989 |
| Decision Date | December 22, 1989 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | GWQ - Full-montage Standard Electroencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations |