RADspeed fit
K-Number: K173517 · 2018-03-30
ApplicantShimadzu Corporation
Decision Date2018-03-30
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RADspeed fit is a medical device manufactured by Shimadzu Corporation. It received FDA 510(k) clearance on 2018-03-30 under approval number K173517. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RADspeed fit?
RADspeed fit is a medical device that received FDA 510(k) clearance on 2018-03-30. It is manufactured by Shimadzu Corporation. The 510(k) number is K173517.
When was RADspeed fit approved by the FDA?
RADspeed fit received FDA 510(k) clearance on 2018-03-30, under approval number K173517.
What company makes RADspeed fit?
RADspeed fit is manufactured by Shimadzu Corporation.
What is the FDA product code for RADspeed fit?
The FDA product code for RADspeed fit is KPR.
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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.