The following data is part of a premarket notification filed by Hc Electronics with the FDA for Group Auditory Trainer Hc 431r.
Device ID | K771357 |
510k Number | K771357 |
Device Name: | GROUP AUDITORY TRAINER HC 431R |
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 | 1977-07-22 |
Decision Date | 1977-07-29 |