uDR 592h, uDR 596i
K-Number: K181413 · 2018-06-27
Decision Date2018-06-27
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uDR 592h, uDR 596i is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2018-06-27 under approval number K181413. 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 uDR 592h, uDR 596i?
uDR 592h, uDR 596i is a medical device that received FDA 510(k) clearance on 2018-06-27. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K181413.
When was uDR 592h, uDR 596i approved by the FDA?
uDR 592h, uDR 596i received FDA 510(k) clearance on 2018-06-27, under approval number K181413.
What company makes uDR 592h, uDR 596i?
uDR 592h, uDR 596i is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uDR 592h, uDR 596i?
The FDA product code for uDR 592h, uDR 596i 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.