OVision Imaging System— 510(k) K200275
Substantially EquivalentOphthalmic Labs, Inc.
FDA 510(k) clearance K200275 for OVision Imaging System, Substantially Equivalent on 2020-03-03. Applicant: Ophthalmic Labs, Inc.. Device class: 2.
Clearance details
- Applicant
- Ophthalmic Labs, Inc.
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milton, MA, US
Recent devices under product code NFJ
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