EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS— 510(k) K043090
Substantially EquivalentPhonic Ear, Inc.
FDA 510(k) clearance K043090 for EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS, Substantially Equivalent on 2004-12-23. Applicant: Phonic Ear, Inc.. Device class: 2.
Clearance details
- Applicant
- Phonic Ear, Inc.
- Product code
- Code LZI
- Device class
- Class 2
- Regulation
- 21 CFR 874.3320
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Petaluma, CA, US
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