PHONIC EAR, MODEL PE475R— 510(k) K862773
Substantially EquivalentPhonic Ear, Inc.
FDA 510(k) clearance K862773 for PHONIC EAR, MODEL PE475R, Substantially Equivalent on 1986-10-09. Applicant: Phonic Ear, Inc.. Device class: 2.
Clearance details
- Applicant
- Phonic Ear, Inc.
- Product code
- Code EPF
- 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
- Mill Valley, CA, US
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