FDA 510(k)

Midmark Smart M9® 灭菌器，Midmark Smart M11® 灭菌器

K号: K233026 · 2024-04-04

决定日期2024-04-04

产品代码FLE

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corporation. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K233026. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer?

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Midmark Corporation. The 510(k) number is K233026.

When did Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer receive FDA 510(k) clearance?

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer received FDA 510(k) clearance on 2024-04-04, under 510(k) number K233026.

Who is the listed applicant for Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer?

The FDA 510(k) record lists Midmark Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer?

The FDA product code for Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer is FLE.

列明Midmark Corporation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。

K253196Midmark 800 数字生命体征设备（1-300-0100，1-300-0200，1-300-0300，1-300-0400）K251626Midmark 牙科输送系统 K201667Midmark 额外口腔成像系统（EOIS）K163337Midmark 和 Ritter M9 及 M11 UltraClave® 自动灭菌器以及 Ritter M9D AutoClave® 自动灭菌器 K161909IQvitals Zone

官方来源

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