Focus Cap
K-Number: K171673 · 2018-01-19
ApplicantGce Medical Corporation
Decision Date2018-01-19
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Focus Cap is a medical device manufactured by Gce Medical Corporation. It received FDA 510(k) clearance on 2018-01-19 under approval number K171673. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Focus Cap?
Focus Cap is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Gce Medical Corporation. The 510(k) number is K171673.
When was Focus Cap approved by the FDA?
Focus Cap received FDA 510(k) clearance on 2018-01-19, under approval number K171673.
What company makes Focus Cap?
Focus Cap is manufactured by Gce Medical Corporation.
What is the FDA product code for Focus Cap?
The FDA product code for Focus Cap is FDF.
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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.