The following data is part of a premarket notification filed by General Hearing Instruments, Inc. with the FDA for Auris Cic.
| Device ID | K943144 |
| 510k Number | K943144 |
| Device Name: | AURIS CIC |
| Classification | Hearing Aid, Air Conduction |
| Applicant | GENERAL HEARING INSTRUMENTS, INC. P.O. BOX 61010 New Orleans, LA 70161 |
| Contact | Roger P Juneau |
| Correspondent | Roger P Juneau GENERAL HEARING INSTRUMENTS, INC. P.O. BOX 61010 New Orleans, LA 70161 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-29 |
| Decision Date | 1994-07-20 |