510(k) K974658 ยท EPF Hearing Aid, Group And Auditory Trainer
INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT
| Applicant | Phonic Ear, Inc., Petaluma CA, US |
| Decision | Substantially Equivalent, Feb 25, 1998 |
| Received | Dec 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974658
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.