The following data is part of a premarket notification filed by Advanced Hearing Instruments with the FDA for Advanced Hearing Instruments - Hearing Aids.
| Device ID | K844728 |
| 510k Number | K844728 |
| Device Name: | ADVANCED HEARING INSTRUMENTS - HEARING AIDS |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ADVANCED HEARING INSTRUMENTS 1 FAIRWAY DR. Novato, CA 94947 |
| Contact | Howard L Hait |
| Correspondent | Howard L Hait ADVANCED HEARING INSTRUMENTS 1 FAIRWAY DR. Novato, CA 94947 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-04 |
| Decision Date | 1985-01-23 |