The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Omni Itc Type Hearing Aid Model U-impulse Sp.
| Device ID | K880286 |
| 510k Number | K880286 |
| Device Name: | OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP |
| 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 | 1988-01-25 |
| Decision Date | 1988-02-23 |