FDA 510(k)

Thayer Medical LiteAire双瓣，可折叠MDI储存室

K号: K160109 · 2017-05-19

决定日期2017-05-19

产品代码NVP

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决定实质等同

器械摘要

Thayer Medical LiteAire 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 2017-05-19 under 510(k) number K160109. 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 Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber?

Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Thayer Medical Corporation. The 510(k) number is K160109.

When did Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber receive FDA 510(k) clearance?

Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber received FDA 510(k) clearance on 2017-05-19, under 510(k) number K160109.

Who is the listed applicant for Thayer Medical LiteAire 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 Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber?

The FDA product code for Thayer Medical LiteAire 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 K210558LiteAire Basic 双阀门可折叠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。