FDA 510(k)

Orchid 安全释放阀（TM）

K号: K212064 · 2022-05-03

决定日期2022-05-03

产品代码QOI

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Orchid Safety Release Valve(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Linear Health Sciences, LLC. It received FDA 510(k) clearance on 2022-05-03 under 510(k) number K212064. The device is classified under product code QOI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Orchid Safety Release Valve(TM)?

Orchid Safety Release Valve(TM) is a medical device that received FDA 510(k) clearance on 2022-05-03. The listed applicant is Linear Health Sciences, LLC. The 510(k) number is K212064.

When did Orchid Safety Release Valve(TM) receive FDA 510(k) clearance?

Orchid Safety Release Valve(TM) received FDA 510(k) clearance on 2022-05-03, under 510(k) number K212064.

Who is the listed applicant for Orchid Safety Release Valve(TM)?

The FDA 510(k) record lists Linear Health Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orchid Safety Release Valve(TM)?

The FDA product code for Orchid Safety Release Valve(TM) is QOI.

列明Linear Health Sciences, LLC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。

K241415Orchid 安全释放阀™K232094Orchid 安全释放阀TM K230266Orchid 安全释放阀

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。