The following data is part of a premarket notification filed by Clinical Diagnostics, Inc. with the FDA for Gordon Diagnostic System Model I.
| Device ID | K854903 |
| 510k Number | K854903 |
| Device Name: | GORDON DIAGNOSTIC SYSTEM MODEL I |
| Classification | Recorder, Attention Task Performance |
| Applicant | CLINICAL DIAGNOSTICS, INC. 300 E. MINERAL AVE., #6 Littleton, CO 80122 |
| Contact | Bruce Meyer |
| Correspondent | Bruce Meyer CLINICAL DIAGNOSTICS, INC. 300 E. MINERAL AVE., #6 Littleton, CO 80122 |
| Product Code | LQD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-09 |
| Decision Date | 1986-06-02 |