The following data is part of a premarket notification filed by General Hearing Instruments, Inc. with the FDA for Auris Ae, Auris Tl, Auris Hs, Auris Ac, Auris Mm, Auris Coe, Auris Cic.
| Device ID | K971399 |
| 510k Number | K971399 |
| Device Name: | AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC |
| Classification | Hearing Aid, Air Conduction |
| Applicant | GENERAL HEARING INSTRUMENTS, INC. 175 BROOKHOLLOW ESPL. Harahan, LA 70123 |
| Contact | Roger P Juneau |
| Correspondent | Roger P Juneau GENERAL HEARING INSTRUMENTS, INC. 175 BROOKHOLLOW ESPL. Harahan, LA 70123 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-15 |
| Decision Date | 1997-06-13 |
| Summary: | summary |