K910972 is an FDA 510(k) clearance for the WALTER GRAPHTEK. This device is classified as a Full-montage Standard Electroencephalograph (Class II - Special Controls, product code GWQ).
Submitted by Inomed Medizintechnik GmbH (Emmendingen, DE). The FDA issued a Cleared decision on October 2, 1991, 209 days after receiving the submission on March 7, 1991.
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 | K910972 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1991 |
| Decision Date | October 02, 1991 |
| Days to Decision | 209 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 |