FDA 510(k)

Cadwell Sierra Summit, Cadwell Sierra Ascent

K号: K162383 · 2017-03-01

决定日期2017-03-01

产品代码IKN

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Cadwell Sierra Summit, Cadwell Sierra Ascent 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 2017-03-01 under 510(k) number K162383. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cadwell Sierra Summit, Cadwell Sierra Ascent?

Cadwell Sierra Summit, Cadwell Sierra Ascent is a medical device that received FDA 510(k) clearance on 2017-03-01. The listed applicant is Cadwell Industries, Inc.. The 510(k) number is K162383.

When did Cadwell Sierra Summit, Cadwell Sierra Ascent receive FDA 510(k) clearance?

Cadwell Sierra Summit, Cadwell Sierra Ascent received FDA 510(k) clearance on 2017-03-01, under 510(k) number K162383.

Who is the listed applicant for Cadwell Sierra Summit, Cadwell Sierra Ascent?

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 Sierra Summit, Cadwell Sierra Ascent?

The FDA product code for Cadwell Sierra Summit, Cadwell Sierra Ascent is IKN.

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

查看所有 12 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。