The following data is part of a premarket notification filed by Hc Electronics with the FDA for Stereo Auditory Trainer (model Pm228).
| Device ID | K810031 |
| 510k Number | K810031 |
| Device Name: | STEREO AUDITORY TRAINER (MODEL PM228) |
| Classification | Hearing Aid, Group And Auditory Trainer |
| Applicant | HC ELECTRONICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EPF |
| CFR Regulation Number | 874.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-06 |
| Decision Date | 1981-03-04 |