FDA 510(k)

BAROnova 注气系统，BAROnova 配件套件

K号: K190985 · 2019-05-14

决定日期2019-05-14

产品代码FCX

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定Unknown

器械摘要

BAROnova Insufflation System, BAROnova Accessory Kit is the device name listed in this FDA 510(k) record. The listed applicant is Baronova, Inc.. It received FDA 510(k) clearance on 2019-05-14 under 510(k) number K190985. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常见问题

What is the BAROnova Insufflation System, BAROnova Accessory Kit?

BAROnova Insufflation System, BAROnova Accessory Kit is a medical device that received FDA 510(k) clearance on 2019-05-14. The listed applicant is Baronova, Inc.. The 510(k) number is K190985.

When did BAROnova Insufflation System, BAROnova Accessory Kit receive FDA 510(k) clearance?

BAROnova Insufflation System, BAROnova Accessory Kit received FDA 510(k) clearance on 2019-05-14, under 510(k) number K190985.

Who is the listed applicant for BAROnova Insufflation System, BAROnova Accessory Kit?

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

What is the FDA product code for BAROnova Insufflation System, BAROnova Accessory Kit?

The FDA product code for BAROnova Insufflation System, BAROnova Accessory Kit is FCX.

列明Baronova, 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。

K191078BAROnova 访问鞘套件 K172575BAROnova 捕获套件，BAROnova 外套管，BAROnova 内窥镜帽

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