Panoura X-ERA PF/NF/MF
K号: K182198 · 2019-01-31
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决定日期2019-01-31
产品代码MUH
咨询委员会DE
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决定实质等同
器械摘要
Panoura X-ERA PF/NF/MF is the device name listed in this FDA 510(k) record. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. It received FDA 510(k) clearance on 2019-01-31 under 510(k) number K182198. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Panoura X-ERA PF/NF/MF?
Panoura X-ERA PF/NF/MF is a medical device that received FDA 510(k) clearance on 2019-01-31. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. The 510(k) number is K182198.
When did Panoura X-ERA PF/NF/MF receive FDA 510(k) clearance?
Panoura X-ERA PF/NF/MF received FDA 510(k) clearance on 2019-01-31, under 510(k) number K182198.
Who is the listed applicant for Panoura X-ERA PF/NF/MF?
The FDA 510(k) record lists The Yoshida Dental Mfg. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Panoura X-ERA PF/NF/MF?
The FDA product code for Panoura X-ERA PF/NF/MF is MUH.
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相关器械（代码：MUH）
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
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