FDA 510(k)

VORTRAN袖带充气器（VCI）

K号: K173914 · 2018-05-25

决定日期2018-05-25

产品代码BSK

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决定实质等同

器械摘要

VORTRAN Cuff Inflator (VCI) is the device name listed in this FDA 510(k) record. The listed applicant is Vortran Medical Technology 1, Inc.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K173914. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VORTRAN Cuff Inflator (VCI)?

VORTRAN Cuff Inflator (VCI) is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Vortran Medical Technology 1, Inc.. The 510(k) number is K173914.

When did VORTRAN Cuff Inflator (VCI) receive FDA 510(k) clearance?

VORTRAN Cuff Inflator (VCI) received FDA 510(k) clearance on 2018-05-25, under 510(k) number K173914.

Who is the listed applicant for VORTRAN Cuff Inflator (VCI)?

The FDA 510(k) record lists Vortran Medical Technology 1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VORTRAN Cuff Inflator (VCI)?

The FDA product code for VORTRAN Cuff Inflator (VCI) is BSK.

列明Vortran Medical Technology 1, 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。

K202219VORTRAN GO2VENT 带有呼气末正压（PEEP）阀 K182292VORTRAN APM-Plus K162968VORTRAN GO2VENT K153733VORTRAN血压计

官方来源

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