The following data is part of a premarket notification filed by Rockwin Corp. with the FDA for Hearing Aids Hb-36m, Hb-36ms, Hb-36mt, Hi-67p, Excel-1000.
| Device ID | K935559 |
| 510k Number | K935559 |
| Device Name: | HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ROCKWIN CORP. 205 N. 2ND ST. Dekalb, IL 60115 |
| Contact | Keith Taylor |
| Correspondent | Keith Taylor ROCKWIN CORP. 205 N. 2ND 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 | 1993-11-17 |
| Decision Date | 1994-01-27 |