FDA 510(k)

HAL 医疗用途（下肢型）

K号: K201559 · 2020-10-02

决定日期2020-10-02

产品代码PHL

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

HAL for Medical Use(Lower Limb type) is the device name listed in this FDA 510(k) record. The listed applicant is Cyberdyne, Inc.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K201559. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HAL for Medical Use(Lower Limb type)?

HAL for Medical Use(Lower Limb type) is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Cyberdyne, Inc.. The 510(k) number is K201559.

When did HAL for Medical Use(Lower Limb type) receive FDA 510(k) clearance?

HAL for Medical Use(Lower Limb type) received FDA 510(k) clearance on 2020-10-02, under 510(k) number K201559.

Who is the listed applicant for HAL for Medical Use(Lower Limb type)?

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

What is the FDA product code for HAL for Medical Use(Lower Limb type)?

The FDA product code for HAL for Medical Use(Lower Limb type) is PHL.

列明Cyberdyne, 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。

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官方来源

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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。