The following data is part of a premarket notification filed by Phonic Ear, Inc. with the FDA for Auditory Trainer Pe150r Fm Receiver.
| Device ID | K893431 |
| 510k Number | K893431 |
| Device Name: | AUDITORY TRAINER PE150R FM RECEIVER |
| Classification | Hearing Aid, Group And Auditory Trainer |
| Applicant | PHONIC EAR, INC. 250 CAMINO ALTO Mill Valley, CA 94941 |
| Contact | Robert L Reinke |
| Correspondent | Robert L Reinke PHONIC EAR, INC. 250 CAMINO ALTO Mill Valley, CA 94941 |
| Product Code | EPF |
| CFR Regulation Number | 874.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-02 |
| Decision Date | 1989-08-21 |