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FDA 510(k)

Ora-Aid

K号: K211851 · 2022-01-11

决定日期2022-01-11
产品代码OLR
决定实质等同

器械摘要

Ora-Aid is the device name listed in this FDA 510(k) record. The listed applicant is Tbm Corporation. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K211851. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

常见问题

What is the Ora-Aid?

Ora-Aid is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Tbm Corporation. The 510(k) number is K211851.

When did Ora-Aid receive FDA 510(k) clearance?

Ora-Aid received FDA 510(k) clearance on 2022-01-11, under 510(k) number K211851.

Who is the listed applicant for Ora-Aid?

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

What is the FDA product code for Ora-Aid?

The FDA product code for Ora-Aid is OLR.

列明Tbm 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。

相关器械(代码:OLR)

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。

官方来源

在 FDA 数据库中查看 →

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。

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