FDA 510(k)

Viva鼻罩（型号：NM4），Numa全脸罩（型号：BMC-FM2）

K号: K163464 · 2017-09-05

决定日期2017-09-05

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

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is the device name listed in this FDA 510(k) record. The listed applicant is Bmc Medical., Ltd.. It received FDA 510(k) clearance on 2017-09-05 under 510(k) number K163464. 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 Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is a medical device that received FDA 510(k) clearance on 2017-09-05. The listed applicant is Bmc Medical., Ltd.. The 510(k) number is K163464.

When did Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) receive FDA 510(k) clearance?

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) received FDA 510(k) clearance on 2017-09-05, under 510(k) number K163464.

Who is the listed applicant for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?

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

What is the FDA product code for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?

The FDA product code for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is BZD.

官方来源

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Viva鼻罩（型号：NM4），Numa全脸罩（型号：BMC-FM2）

器械摘要

常见问题

相关临床试验

相关器械（代码：BZD）

官方来源