The following data is part of a premarket notification filed by Intelligent Software Systems, Inc. with the FDA for Speakeasy Commun. System-comm. Prothesis.
| Device ID | K802687 |
| 510k Number | K802687 |
| Device Name: | SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS |
| Classification | System, Communication, Powered |
| Applicant | INTELLIGENT SOFTWARE SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ILQ |
| CFR Regulation Number | 890.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-29 |
| Decision Date | 1981-02-04 |