FDA 510(k)

MD-320W 超声生物显微镜

K号: K213070 · 2021-11-18

决定日期2021-11-18

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

MD-320W Ultrasound Biomicroscope is the device name listed in this FDA 510(k) record. The listed applicant is MEDA Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K213070. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MD-320W Ultrasound Biomicroscope?

MD-320W Ultrasound Biomicroscope is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is MEDA Co., Ltd.. The 510(k) number is K213070.

When did MD-320W Ultrasound Biomicroscope receive FDA 510(k) clearance?

MD-320W Ultrasound Biomicroscope received FDA 510(k) clearance on 2021-11-18, under 510(k) number K213070.

Who is the listed applicant for MD-320W Ultrasound Biomicroscope?

FDA 510(k)记录将MEDA Co., Ltd.列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for MD-320W Ultrasound Biomicroscope?

The FDA product code for MD-320W Ultrasound Biomicroscope is IYO.

列明MEDA Co., Ltd.为申报人的其他记录

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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