The following data is part of a premarket notification filed by Rockwin Corp. with the FDA for Hi-69e, Hi-69n, Hi-69p.
| Device ID | K974129 |
| 510k Number | K974129 |
| Device Name: | HI-69E, HI-69N, HI-69P |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ROCKWIN CORP. 105 NORTH FIRST ST. Dekalb, IL 60115 |
| Contact | Keith Taylor |
| Correspondent | Keith Taylor ROCKWIN CORP. 105 NORTH FIRST ST. Dekalb, IL 60115 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-03 |
| Decision Date | 1997-12-12 |