FDA 510(k)

Combined Aerobika OPEP and VersaPAP设备

K号: K183108 · 2019-08-16

决定日期2019-08-16

产品代码BWF

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决定实质等同

器械摘要

Combined Aerobika OPEP and VersaPAP device is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K183108. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Combined Aerobika OPEP and VersaPAP device?

Combined Aerobika OPEP and VersaPAP device is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Trudell Medical International. The 510(k) number is K183108.

When did Combined Aerobika OPEP and VersaPAP device receive FDA 510(k) clearance?

Combined Aerobika OPEP and VersaPAP device received FDA 510(k) clearance on 2019-08-16, under 510(k) number K183108.

Who is the listed applicant for Combined Aerobika OPEP and VersaPAP device?

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

What is the FDA product code for Combined Aerobika OPEP and VersaPAP device?

The FDA product code for Combined Aerobika OPEP and VersaPAP device is BWF.

列明Trudell Medical International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。

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