PHONIC EAR, MODEL PE 1800— 510(k) K862162
Substantially EquivalentPhonic Ear, Inc.
FDA 510(k) clearance K862162 for PHONIC EAR, MODEL PE 1800, Substantially Equivalent on 1986-07-18. Applicant: Phonic Ear, Inc.. Device class: 2.
Clearance details
- Applicant
- Phonic Ear, Inc.
- Product code
- Code ETW
- Device class
- Class 2
- Regulation
- 21 CFR 874.3310
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mill Valley, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.