R:GEN
K号: K220974 · 2022-12-27
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决定日期2022-12-27
产品代码HQF
咨询委员会OP
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决定实质等同
器械摘要
R:GEN is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Vision, Inc.. It received FDA 510(k) clearance on 2022-12-27 under 510(k) number K220974. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the R:GEN?
R:GEN is a medical device that received FDA 510(k) clearance on 2022-12-27. The listed applicant is Lutronic Vision, Inc.. The 510(k) number is K220974.
When did R:GEN receive FDA 510(k) clearance?
R:GEN received FDA 510(k) clearance on 2022-12-27, under 510(k) number K220974.
Who is the listed applicant for R:GEN?
The FDA 510(k) record lists Lutronic Vision, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for R:GEN?
The FDA product code for R:GEN is HQF.
相关器械（代码：HQF）
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官方来源
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