BOSS™
K号: K223700 · 2024-08-16
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决定日期2024-08-16
产品代码MXK
咨询委员会OP
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决定实质等同
器械摘要
BOSS™ is the device name listed in this FDA 510(k) record. The listed applicant is Intelon Optics, Inc.. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K223700. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BOSS™?
BOSS™ is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Intelon Optics, Inc.. The 510(k) number is K223700.
When did BOSS™ receive FDA 510(k) clearance?
BOSS™ received FDA 510(k) clearance on 2024-08-16, under 510(k) number K223700.
Who is the listed applicant for BOSS™?
The FDA 510(k) record lists Intelon Optics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BOSS™?
The FDA product code for BOSS™ is MXK.
相关器械（代码：MXK）
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官方来源
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