FDA 510(k)

iCodeConnect

K号: K160127 · 2016-11-10

决定日期2016-11-10

产品代码BZD

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决定实质等同

器械摘要

iCodeConnect is the device name listed in this FDA 510(k) record. The listed applicant is 3B Medical, Inc.. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K160127. 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 iCodeConnect?

iCodeConnect is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is 3B Medical, Inc.. The 510(k) number is K160127.

When did iCodeConnect receive FDA 510(k) clearance?

iCodeConnect received FDA 510(k) clearance on 2016-11-10, under 510(k) number K160127.

Who is the listed applicant for iCodeConnect?

The FDA 510(k) record lists 3B Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iCodeConnect?

The FDA product code for iCodeConnect is BZD.

列明3B Medical, 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。

K212263Luna G3 BPAP 系统 K201620Luna® G3 BPAP 25A K200496Aer X K153387Luna CPAP 和自动 CPAP 系统

官方来源

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