The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for U-impulse Air Conduction In-the-canal Hearing Aid.
| Device ID | K873560 |
| 510k Number | K873560 |
| Device Name: | U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-02 |
| Decision Date | 1987-09-29 |