FDA 510(k)

iPEP系统及vPEP

K号: K160636 · 2016-08-03

决定日期2016-08-03

产品代码BWF

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决定实质等同

器械摘要

iPEP System and vPEP is the device name listed in this FDA 510(k) record. The listed applicant is D R Burton Healthcare, LLC. It received FDA 510(k) clearance on 2016-08-03 under 510(k) number K160636. 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 iPEP System and vPEP?

iPEP System and vPEP is a medical device that received FDA 510(k) clearance on 2016-08-03. The listed applicant is D R Burton Healthcare, LLC. The 510(k) number is K160636.

When did iPEP System and vPEP receive FDA 510(k) clearance?

iPEP System and vPEP received FDA 510(k) clearance on 2016-08-03, under 510(k) number K160636.

Who is the listed applicant for iPEP System and vPEP?

The FDA 510(k) record lists D R Burton Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iPEP System and vPEP?

The FDA product code for iPEP System and vPEP is BWF.

列明D R Burton Healthcare, LLC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。

K192000D R Burton OxyPAP

官方来源

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