The following data is part of a premarket notification filed by Phonic Ear, Inc. with the FDA for Phonic Ear Pe 467r-pe 461t.
| Device ID | K832080 |
| 510k Number | K832080 |
| Device Name: | PHONIC EAR PE 467R-PE 461T |
| Classification | Hearing Aid, Group And Auditory Trainer |
| Applicant | PHONIC EAR, INC. 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 | 1983-06-28 |
| Decision Date | 1983-08-01 |