NIRA型号2
K号: K222685 · 2023-02-08
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决定日期2023-02-08
产品代码OHS
咨询委员会SU
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决定实质等同
器械摘要
NIRA Model 2 is the device name listed in this FDA 510(k) record. The listed applicant is Dermal Photonics Corp. It received FDA 510(k) clearance on 2023-02-08 under 510(k) number K222685. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NIRA Model 2?
NIRA Model 2 is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Dermal Photonics Corp. The 510(k) number is K222685.
When did NIRA Model 2 receive FDA 510(k) clearance?
NIRA Model 2 received FDA 510(k) clearance on 2023-02-08, under 510(k) number K222685.
Who is the listed applicant for NIRA Model 2?
The FDA 510(k) record lists Dermal Photonics Corp as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NIRA Model 2?
The FDA product code for NIRA Model 2 is OHS.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：OHS）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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