The following data is part of a premarket notification filed by Phonic Ear, Inc. with the FDA for Easylistener 2 Fm, Radium Fm And Vocalight Infrared Sound Field Systems.
| Device ID | K043090 |
| 510k Number | K043090 |
| Device Name: | EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS |
| Classification | Device, Assistive Listening |
| Applicant | PHONIC EAR, INC. 3880 CYPRESS DR. Petaluma, CA 94954 -7600 |
| Contact | Todd Bissey |
| Correspondent | Todd Bissey PHONIC EAR, INC. 3880 CYPRESS DR. Petaluma, CA 94954 -7600 |
| Product Code | LZI |
| CFR Regulation Number | 874.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-08 |
| Decision Date | 2004-12-23 |
| Summary: | summary |