Digital Intraoral Imaging Plate System
K-Number: K192766 · 2019-12-05
ApplicantFsusen Technology Co., Ltd.
Decision Date2019-12-05
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Digital Intraoral Imaging Plate System is a medical device manufactured by Fsusen Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-05 under approval number K192766. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Digital Intraoral Imaging Plate System?
Digital Intraoral Imaging Plate System is a medical device that received FDA 510(k) clearance on 2019-12-05. It is manufactured by Fsusen Technology Co., Ltd.. The 510(k) number is K192766.
When was Digital Intraoral Imaging Plate System approved by the FDA?
Digital Intraoral Imaging Plate System received FDA 510(k) clearance on 2019-12-05, under approval number K192766.
What company makes Digital Intraoral Imaging Plate System?
Digital Intraoral Imaging Plate System is manufactured by Fsusen Technology Co., Ltd..
What is the FDA product code for Digital Intraoral Imaging Plate System?
The FDA product code for Digital Intraoral Imaging Plate System is MUH.
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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.