Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
K-Number: K243030 · 2024-10-25
ApplicantUlike Co., Ltd.
Decision Date2024-10-25
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) is a medical device manufactured by Ulike Co., Ltd.. It received FDA 510(k) clearance on 2024-10-25 under approval number K243030. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)?
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) is a medical device that received FDA 510(k) clearance on 2024-10-25. It is manufactured by Ulike Co., Ltd.. The 510(k) number is K243030.
When was Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) approved by the FDA?
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) received FDA 510(k) clearance on 2024-10-25, under approval number K243030.
What company makes Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)?
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) is manufactured by Ulike Co., Ltd..
What is the FDA product code for Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)?
The FDA product code for Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) is OHT.
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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.