PHONIC EAR MODELS PE 811CS AND PE 811CST— 510(k) K864672
Substantially EquivalentPhonic Ear, Inc.
FDA 510(k) clearance K864672 for PHONIC EAR MODELS PE 811CS AND PE 811CST, Substantially Equivalent on 1987-02-20. 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
Recent devices under product code ESD
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Data sourced from openFDA. This site is unofficial and independent of the FDA.