FDA 510(k)

Oxevision 睡眠设备

K号: K233618 · 2024-04-03

决定日期2024-04-03

产品代码LEL

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决定实质等同

器械摘要

Oxevision Sleep Device is the device name listed in this FDA 510(k) record. The listed applicant is Oxehealth Limited. It received FDA 510(k) clearance on 2024-04-03 under 510(k) number K233618. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Oxevision Sleep Device?

Oxevision Sleep Device is a medical device that received FDA 510(k) clearance on 2024-04-03. The listed applicant is Oxehealth Limited. The 510(k) number is K233618.

When did Oxevision Sleep Device receive FDA 510(k) clearance?

Oxevision Sleep Device received FDA 510(k) clearance on 2024-04-03, under 510(k) number K233618.

Who is the listed applicant for Oxevision Sleep Device?

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

What is the FDA product code for Oxevision Sleep Device?

The FDA product code for Oxevision Sleep Device is LEL.

列明Oxehealth Limited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。

K251200生命体征 K243687生命体征 K220899Oxehealth 生命体征监测仪 K211906生命体征

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。