K053386 is an FDA 510(k) clearance for the XLTEK EMU40 EEG HEADBOX, MODEL PK1072. This device is classified as a Full-montage Standard Electroencephalograph (Class II - Special Controls, product code GWQ).
Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on April 21, 2006, 137 days after receiving the submission on December 5, 2005.
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 | K053386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2005 |
| Decision Date | April 21, 2006 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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 |