XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System— 510(k) K193319
Substantially EquivalentVasoptic Medical, Inc.
FDA 510(k) clearance K193319 for XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System, Substantially Equivalent on 2020-06-01. Applicant: Vasoptic Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Vasoptic Medical, Inc.
- 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
- Baltimore, MD, US
Recent devices under product code HKI
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