FDR SE Lite
K-Number: K192440 · 2019-11-01
ApplicantFujifilm Corporation
Decision Date2019-11-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FDR SE Lite is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-11-01 under approval number K192440. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FDR SE Lite?
FDR SE Lite is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by Fujifilm Corporation. The 510(k) number is K192440.
When was FDR SE Lite approved by the FDA?
FDR SE Lite received FDA 510(k) clearance on 2019-11-01, under approval number K192440.
What company makes FDR SE Lite?
FDR SE Lite is manufactured by Fujifilm Corporation.
What is the FDA product code for FDR SE Lite?
The FDA product code for FDR SE Lite is MQB.
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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.