The following data is part of a premarket notification filed by Inomed Medizintechnik Gmbh with the FDA for Walter Graphtek.
| Device ID | K910972 |
| 510k Number | K910972 |
| Device Name: | WALTER GRAPHTEK |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | INOMED MEDIZINTECHNIK GMBH IM HAUSGRUEN 29 Emmendingen, DE 79321 |
| Contact | Saschka Busch |
| Correspondent | Saschka Busch INOMED MEDIZINTECHNIK GMBH IM HAUSGRUEN 29 Emmendingen, DE 79321 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-07 |
| Decision Date | 1991-10-02 |