K093223 is an FDA 510(k) clearance for the COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG. This device is classified as a Full-montage Standard Electroencephalograph (Class II - Special Controls, product code GWQ).
Submitted by Compumedics Limited (Abbotsford, Victoria, AU). The FDA issued a Cleared decision on January 15, 2010, 94 days after receiving the submission on October 13, 2009.
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 | K093223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 2009 |
| Decision Date | January 15, 2010 |
| Days to Decision | 94 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 |