FDA 510(k)

Cadwell Apollo System

K号: K180269 · 2018-07-17

决定日期2018-07-17

产品代码GWQ

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决定实质等同

器械摘要

Cadwell Apollo System is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2018-07-17 under 510(k) number K180269. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cadwell Apollo System?

Cadwell Apollo System is a medical device that received FDA 510(k) clearance on 2018-07-17. The listed applicant is Cadwell Industries, Inc.. The 510(k) number is K180269.

When did Cadwell Apollo System receive FDA 510(k) clearance?

Cadwell Apollo System received FDA 510(k) clearance on 2018-07-17, under 510(k) number K180269.

Who is the listed applicant for Cadwell Apollo System?

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

What is the FDA product code for Cadwell Apollo System?

The FDA product code for Cadwell Apollo System is GWQ.

列明Cadwell Industries, 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。

K261442Charlotte ACC25 表面电极阵列；Charlotte ACC25 可重复使用表面电极阵列 K250851Hypnos (369054-200)K242424Bluebird 单次使用呼吸用力带 K230415Cadwell Guardian K201819Cadwell Apollo System K192624ApneaTrak

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