FDA 510(k)

LiteAire Basic 双阀门可折叠MDI储存室

K号: K210558 · 2022-04-01

决定日期2022-04-01

产品代码NVP

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决定实质等同

器械摘要

LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber is the device name listed in this FDA 510(k) record. The listed applicant is Thayer Medical Corporation. It received FDA 510(k) clearance on 2022-04-01 under 510(k) number K210558. The device is classified under product code NVP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber?

LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber is a medical device that received FDA 510(k) clearance on 2022-04-01. The listed applicant is Thayer Medical Corporation. The 510(k) number is K210558.

When did LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber receive FDA 510(k) clearance?

LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber received FDA 510(k) clearance on 2022-04-01, under 510(k) number K210558.

Who is the listed applicant for LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber?

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

What is the FDA product code for LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber?

The FDA product code for LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber is NVP.

列明Thayer Medical 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。

K233553MiniSpacer® 1024, 1025, 1543 和 1024A, 1025A, 1543A 双喷剂吸入剂适配器 K160109Thayer Medical LiteAire双瓣，可折叠MDI储存室

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。