FLUOROspeed
K-Number: K191877 · 2019-08-05
ApplicantShimadzu Corporation
Decision Date2019-08-05
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FLUOROspeed is a medical device manufactured by Shimadzu Corporation. It received FDA 510(k) clearance on 2019-08-05 under approval number K191877. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FLUOROspeed?
FLUOROspeed is a medical device that received FDA 510(k) clearance on 2019-08-05. It is manufactured by Shimadzu Corporation. The 510(k) number is K191877.
When was FLUOROspeed approved by the FDA?
FLUOROspeed received FDA 510(k) clearance on 2019-08-05, under approval number K191877.
What company makes FLUOROspeed?
FLUOROspeed is manufactured by Shimadzu Corporation.
What is the FDA product code for FLUOROspeed?
The FDA product code for FLUOROspeed is JAA.
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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.