FDA 510(k)

Watch-PAT300

K号: K180775 · 2018-08-17

决定日期2018-08-17

产品代码MNR

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决定实质等同

器械摘要

Watch-PAT300 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 2018-08-17 under 510(k) number K180775. 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 Watch-PAT300?

Watch-PAT300 is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K180775.

When did Watch-PAT300 receive FDA 510(k) clearance?

Watch-PAT300 received FDA 510(k) clearance on 2018-08-17, under 510(k) number K180775.

Who is the listed applicant for Watch-PAT300?

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 Watch-PAT300?

The FDA product code for Watch-PAT300 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 K250460WatchPAT400 (WP400)K223675WatchPAT ONE (WP1)K211557EndoPATx K222331WatchPAT300 (WP300)K203839WatchPAT200U (WP200U)

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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。