510(k) K043090 ยท LZI Device, Assistive Listening
EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
| Applicant | Phonic Ear, Inc., Petaluma CA, US |
| Decision | Substantially Equivalent, Dec 23, 2004 |
| Received | Nov 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043090
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.