Glaucoma Module
K-Number: K200954 · 2020-08-03
ApplicantTopcon Healthcare Solutions, Inc.
Decision Date2020-08-03
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Glaucoma Module is a medical device manufactured by Topcon Healthcare Solutions, Inc.. It received FDA 510(k) clearance on 2020-08-03 under approval number K200954. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Glaucoma Module?
Glaucoma Module is a medical device that received FDA 510(k) clearance on 2020-08-03. It is manufactured by Topcon Healthcare Solutions, Inc.. The 510(k) number is K200954.
When was Glaucoma Module approved by the FDA?
Glaucoma Module received FDA 510(k) clearance on 2020-08-03, under approval number K200954.
What company makes Glaucoma Module?
Glaucoma Module is manufactured by Topcon Healthcare Solutions, Inc..
What is the FDA product code for Glaucoma Module?
The FDA product code for Glaucoma Module is NFJ.
Related Devices (Code: NFJ)
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.