FDA 510(k)

SQA-iO 精子质量分析仪

K号: K220828 · 2023-08-07

决定日期2023-08-07

产品代码POV

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决定实质等同

器械摘要

SQA-iO Sperm Quality Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronic Systems , Ltd.. It received FDA 510(k) clearance on 2023-08-07 under 510(k) number K220828. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SQA-iO Sperm Quality Analyzer?

SQA-iO Sperm Quality Analyzer is a medical device that received FDA 510(k) clearance on 2023-08-07. The listed applicant is Medical Electronic Systems , Ltd.. The 510(k) number is K220828.

When did SQA-iO Sperm Quality Analyzer receive FDA 510(k) clearance?

SQA-iO Sperm Quality Analyzer received FDA 510(k) clearance on 2023-08-07, under 510(k) number K220828.

Who is the listed applicant for SQA-iO Sperm Quality Analyzer?

The FDA 510(k) record lists Medical Electronic Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SQA-iO Sperm Quality Analyzer?

The FDA product code for SQA-iO Sperm Quality Analyzer is POV.

列明Medical Electronic Systems , 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。

K243114SQA-iOw 精子质量分析仪 K241628YO家用精子检测 K161493YO家用精子检测

官方来源

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