Non-Mydriatic Retinal Camera NW500
K-Number: K221111 · 2022-08-29
ApplicantTopcon Corporation
Decision Date2022-08-29
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Non-Mydriatic Retinal Camera NW500 is a medical device manufactured by Topcon Corporation. It received FDA 510(k) clearance on 2022-08-29 under approval number K221111. 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 Non-Mydriatic Retinal Camera NW500?
Non-Mydriatic Retinal Camera NW500 is a medical device that received FDA 510(k) clearance on 2022-08-29. It is manufactured by Topcon Corporation. The 510(k) number is K221111.
When was Non-Mydriatic Retinal Camera NW500 approved by the FDA?
Non-Mydriatic Retinal Camera NW500 received FDA 510(k) clearance on 2022-08-29, under approval number K221111.
What company makes Non-Mydriatic Retinal Camera NW500?
Non-Mydriatic Retinal Camera NW500 is manufactured by Topcon Corporation.
What is the FDA product code for Non-Mydriatic Retinal Camera NW500?
The FDA product code for Non-Mydriatic Retinal Camera NW500 is HKI.
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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.