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FDA 510(k)

翼智智能肺功能仪和峰值流速仪

K号: K152276 · 2016-06-03

申请人Sparo, Inc.
决定日期2016-06-03
产品代码BZH
咨询委员会AN 请注意,由于您没有提供完整的医疗设备监管文本,我无法提供完整的翻译。如果您能提供完整的文本,我将很乐意为您翻译。
决定实质等同

器械摘要

Wing Smart FEVI and Peak Flow Meter is the device name listed in this FDA 510(k) record. The listed applicant is Sparo, Inc.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K152276. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wing Smart FEVI and Peak Flow Meter?

Wing Smart FEVI and Peak Flow Meter is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Sparo, Inc.. The 510(k) number is K152276.

When did Wing Smart FEVI and Peak Flow Meter receive FDA 510(k) clearance?

Wing Smart FEVI and Peak Flow Meter received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152276.

Who is the listed applicant for Wing Smart FEVI and Peak Flow Meter?

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

What is the FDA product code for Wing Smart FEVI and Peak Flow Meter?

The FDA product code for Wing Smart FEVI and Peak Flow Meter is BZH.

相关临床试验

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:BZH)

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

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