FDA 510(k)

WatchPAT400 (WP400)

K号: K250460 · 2025-09-05

决定日期2025-09-05

产品代码MNR

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决定实质等同

器械摘要

WatchPAT400 (WP400) is the device name listed in this FDA 510(k) record. The listed applicant is Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K250460. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the WatchPAT400 (WP400)?

WatchPAT400 (WP400) is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K250460.

When did WatchPAT400 (WP400) receive FDA 510(k) clearance?

WatchPAT400 (WP400) received FDA 510(k) clearance on 2025-09-05, under 510(k) number K250460.

Who is the listed applicant for WatchPAT400 (WP400)?

FDA 510(k)记录中列出了Itamar Medical，Ltd.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 WatchPAT400 (WP400)?

The FDA product code for WatchPAT400 (WP400) is MNR.

列明Itamar Medical , 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。

K254042WatchPAT SW K223675WatchPAT ONE (WP1)K211557EndoPATx K222331WatchPAT300 (WP300)K203839WatchPAT200U (WP200U)K183559WatchPAT ONE

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。