POST-AURICULAR HEARING AID MODEL PE 600CHD— 510(k) K844860
Substantially EquivalentPhonic Ear, Inc.
FDA 510(k) clearance K844860 for POST-AURICULAR HEARING AID MODEL PE 600CHD, Substantially Equivalent on 1985-03-27. Applicant: Phonic Ear, Inc.. Device class: 1.
Clearance details
- Applicant
- Phonic Ear, Inc.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- 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.