FDA 510(k)

Proneb Max

K号: K191270 · 2020-01-23

决定日期2020-01-23

产品代码CAF

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决定实质等同

器械摘要

Proneb Max is the device name listed in this FDA 510(k) record. The listed applicant is Pari Respiratory Equipment, Inc.. It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K191270. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Proneb Max?

Proneb Max is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Pari Respiratory Equipment, Inc.. The 510(k) number is K191270.

When did Proneb Max receive FDA 510(k) clearance?

Proneb Max received FDA 510(k) clearance on 2020-01-23, under 510(k) number K191270.

Who is the listed applicant for Proneb Max?

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

What is the FDA product code for Proneb Max?

The FDA product code for Proneb Max is CAF.

列明Pari Respiratory Equipment, Inc.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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相关器械（代码：CAF）

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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