HYPER AiR
K-Number: K210001 · 2021-04-30
Decision Date2021-04-30
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HYPER AiR is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2021-04-30 under approval number K210001. 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 AiR?
HYPER AiR is a medical device that received FDA 510(k) clearance on 2021-04-30. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K210001.
When was HYPER AiR approved by the FDA?
HYPER AiR received FDA 510(k) clearance on 2021-04-30, under approval number K210001.
What company makes HYPER AiR?
HYPER AiR is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for HYPER AiR?
The FDA product code for HYPER AiR 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.