HYPER DLR
K-Number: K193210 · 2020-08-04
Decision Date2020-08-04
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HYPER DLR is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2020-08-04 under approval number K193210. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HYPER DLR?
HYPER DLR is a medical device that received FDA 510(k) clearance on 2020-08-04. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K193210.
When was HYPER DLR approved by the FDA?
HYPER DLR received FDA 510(k) clearance on 2020-08-04, under approval number K193210.
What company makes HYPER DLR?
HYPER DLR is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for HYPER DLR?
The FDA product code for HYPER DLR is KPS.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
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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.