EARLENS— 510(k) K854311
Substantially EquivalentSound Acoustic Systems, Ltd.
FDA 510(k) clearance K854311 for EARLENS, Substantially Equivalent on 1986-04-14. Applicant: Sound Acoustic Systems, Ltd.. Device class: 1.
Clearance details
- Applicant
- Sound Acoustic Systems, Ltd.
- 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
- Laguna, CA, US
Recent devices under product code ESD
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