FDA 510(k)

医疗HAL下肢型（HAL-ML）

K号: K233695 · 2024-05-07

决定日期2024-05-07

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

Medical HAL Lower Limb Type (HAL-ML) is the device name listed in this FDA 510(k) record. The listed applicant is Cyberdyne, Inc.. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K233695. 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 Medical HAL Lower Limb Type (HAL-ML)?

Medical HAL Lower Limb Type (HAL-ML) is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Cyberdyne, Inc.. The 510(k) number is K233695.

When did Medical HAL Lower Limb Type (HAL-ML) receive FDA 510(k) clearance?

Medical HAL Lower Limb Type (HAL-ML) received FDA 510(k) clearance on 2024-05-07, under 510(k) number K233695.

Who is the listed applicant for Medical HAL Lower Limb Type (HAL-ML)?

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 Medical HAL Lower Limb Type (HAL-ML)?

The FDA product code for Medical HAL Lower Limb Type (HAL-ML) 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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