FDA 510(k)

DeVilbiss DV6WM 无线调制解调器

K号: K152810 · 2016-01-21

决定日期2016-01-21

产品代码BZD

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

DeVilbiss DV6WM Wireless Modem is the device name listed in this FDA 510(k) record. The listed applicant is Devilbiss Healthcare, LLC. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K152810. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DeVilbiss DV6WM Wireless Modem?

DeVilbiss DV6WM Wireless Modem is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Devilbiss Healthcare, LLC. The 510(k) number is K152810.

When did DeVilbiss DV6WM Wireless Modem receive FDA 510(k) clearance?

DeVilbiss DV6WM Wireless Modem received FDA 510(k) clearance on 2016-01-21, under 510(k) number K152810.

Who is the listed applicant for DeVilbiss DV6WM Wireless Modem?

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

What is the FDA product code for DeVilbiss DV6WM Wireless Modem?

The FDA product code for DeVilbiss DV6WM Wireless Modem is BZD.

列明Devilbiss 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。

K253549DeVilbiss 5 升制氧机（555）K250805DeVilbiss PulmO2 10 升制氧机（1060AW）K172648Drive DeVilbiss iGo 2 便携式制氧机

官方来源

在 FDA 数据库中查看 →

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。