EXCELSIOR— 510(k) K130453
Substantially EquivalentEyekor, LLC
FDA 510(k) clearance K130453 for EXCELSIOR, Substantially Equivalent on 2013-04-02. Applicant: Eyekor, LLC. Device class: 2.
Clearance details
- Applicant
- Eyekor, LLC
- 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
- North Reading, MA, US
Recent devices under product code NFJ
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