XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System— 510(k) K193319

Substantially Equivalent

Vasoptic 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..

Clearance details

Applicant: Vasoptic Medical, Inc.
Product code: Code HKI
Advisory panel: Ophthalmic
Date received: 2019-12-02
Decision date: 2020-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

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