FDA 510(k)

Midmark 800 数字生命体征设备（1-300-0100，1-300-0200，1-300-0300，1-300-0400）

K号: K253196 · 2026-06-12

决定日期2026-06-12

产品代码MWI

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) is the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corporation. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253196. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)?

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Midmark Corporation. The 510(k) number is K253196.

When did Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) receive FDA 510(k) clearance?

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253196.

Who is the listed applicant for Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)?

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 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)?

The FDA product code for Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) is MWI.

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。

K251626Midmark 牙科输送系统 K233026Midmark Smart M9® 灭菌器，Midmark Smart M11® 灭菌器 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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