The following data is part of a premarket notification filed by Resound Corp. with the FDA for Resound Itc Hearing Enhancement Sys Hes2, W/remote.
| Device ID | K891011 |
| 510k Number | K891011 |
| Device Name: | RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Contact | Vincent Pluvinage |
| Correspondent | Vincent Pluvinage RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-28 |
| Decision Date | 1989-03-29 |