RetCam Envision
K-Number: K203500 · 2021-04-13
Decision Date2021-04-13
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
RetCam Envision is a medical device manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2021-04-13 under approval number K203500. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RetCam Envision?
RetCam Envision is a medical device that received FDA 510(k) clearance on 2021-04-13. It is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K203500.
When was RetCam Envision approved by the FDA?
RetCam Envision received FDA 510(k) clearance on 2021-04-13, under approval number K203500.
What company makes RetCam Envision?
RetCam Envision is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).
What is the FDA product code for RetCam Envision?
The FDA product code for RetCam Envision is HKI.
Other Devices by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.