FDA 510(k)

ViSiGi LUX（5332）；ViSiGi LUX（5336）；ViSiGi LUX（5340）

K号: K234033 · 2024-05-06

决定日期2024-05-06

产品代码KNT

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决定实质等同

器械摘要

ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories, LLC. It received FDA 510(k) clearance on 2024-05-06 under 510(k) number K234033. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)?

ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) is a medical device that received FDA 510(k) clearance on 2024-05-06. The listed applicant is Boehringer Laboratories, LLC. The 510(k) number is K234033.

When did ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) receive FDA 510(k) clearance?

ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) received FDA 510(k) clearance on 2024-05-06, under 510(k) number K234033.

Who is the listed applicant for ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)?

FDA 510(k)记录显示，Boehringer Laboratories, LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)?

The FDA product code for ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) is KNT.

列明Boehringer Laboratories, 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。

K26189052Fr ViSiGi LUX™；52Fr ViSiGi 3D®K243399Boehringer Laboratories肝脏拉钩

相关器械（代码：KNT）

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。

K26189052Fr ViSiGi LUX™；52Fr ViSiGi 3D®Boehringer Laboratories, LLC K253514明尼苏达四腔食管胃填塞管 - 18 French (0092220)；布莱克莫尔食管鼻胃管 - 20 French (0092100)；布莱克莫尔食管鼻胃管 - 16 French (0092300)C.R. Bard, Inc.K250389XNY一次性胃腔校准管Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd K243228Flexi-Seal AIR（带 ENFit 连接器）Convatec K242336hygh-tec 排液IIAmb Medtec K242901ZZIREN™ 口胃管；ZZIREN™ SGT 口胃管 - 32 Fr（ZZ-SGT-32）；ZZIREN™ SGT 口胃管 - 36 Fr（ZZ-SGT-36）；ZZIREN™ SGT 口胃管 - 40 Fr（ZZ-SGT-40）；ZZIREN™ GBT 口胃管 - 32 Fr（ZZ-GBT-32）；ZZIREN™ GBT 口胃管 - 36 Fr（ZZ-GBT-36）；ZZIREN™ GBT 口胃管 - 40 Fr（ZZ-GBT-40）Tools For Surgery, LLC

官方来源

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