The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Impulse Tvc (richards, Omni, Marcon).
| Device ID | K881143 |
| 510k Number | K881143 |
| Device Name: | IMPULSE TVC (RICHARDS, OMNI, MARCON) |
| 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 | 1988-03-17 |
| Decision Date | 1988-05-18 |