OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN— 510(k) K092374
Substantially EquivalentOphthalmic Imaging Systems
FDA 510(k) clearance K092374 for OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN, Substantially Equivalent on 2009-11-17. Applicant: Ophthalmic Imaging Systems. Device class: 2.
Clearance details
- Applicant
- Ophthalmic Imaging Systems
- Product code
- Code HKI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
Recent devices under product code HKI
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