The following data is part of a premarket notification filed by Colorado Hearing Systems, Inc. with the FDA for Visual Reinforce. Audio Cassette Unit: Basic & Adv.
| Device ID | K880259 |
| 510k Number | K880259 |
| Device Name: | VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV |
| Classification | Apparatus, Visual Reinforcement Audiometric |
| Applicant | COLORADO HEARING SYSTEMS, INC. P.O. BOX 20324 Denver, CO 80220 |
| Contact | Arlan D Rogers/cr |
| Correspondent | Arlan D Rogers/cr COLORADO HEARING SYSTEMS, INC. P.O. BOX 20324 Denver, CO 80220 |
| Product Code | LYN |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-22 |
| Decision Date | 1989-04-03 |