The following data is part of a premarket notification filed by Discovery Engineering Intl., Inc. with the FDA for Dei Model 20 Eeg.
| Device ID | K961718 |
| 510k Number | K961718 |
| Device Name: | DEI MODEL 20 EEG |
| Classification | Device, Biofeedback |
| Applicant | DISCOVERY ENGINEERING INTL., INC. 3115 WESTWOOD DR. Topeka, KS 66614 -2741 |
| Contact | Rex Hartzell |
| Correspondent | Rex Hartzell DISCOVERY ENGINEERING INTL., INC. 3115 WESTWOOD DR. Topeka, KS 66614 -2741 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-02 |
| Decision Date | 1996-08-27 |