RetCam Envision— 510(k) K203500

Substantially Equivalent

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

FDA 510(k) clearance K203500 for RetCam Envision, Substantially Equivalent on 2021-04-13. Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).

Clearance details

Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Product code: Code HKI
Advisory panel: Ophthalmic
Date received: 2020-11-30
Decision date: 2021-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

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