InferOperate Suite
K-Number: K250237 · 2025-09-15
Decision Date2025-09-15
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
InferOperate Suite is a medical device manufactured by Beijing Infervision Healthcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-15 under approval number K250237. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the InferOperate Suite?
InferOperate Suite is a medical device that received FDA 510(k) clearance on 2025-09-15. It is manufactured by Beijing Infervision Healthcare Medical Technology Co., Ltd.. The 510(k) number is K250237.
When was InferOperate Suite approved by the FDA?
InferOperate Suite received FDA 510(k) clearance on 2025-09-15, under approval number K250237.
What company makes InferOperate Suite?
InferOperate Suite is manufactured by Beijing Infervision Healthcare Medical Technology Co., Ltd..
What is the FDA product code for InferOperate Suite?
The FDA product code for InferOperate Suite is QIH.
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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.