FDA 510(k)

BEMER 疗法系统，BEMER Classic Set, BEMER Pro-Set

K号: K210174 · 2021-02-04

决定日期2021-02-04

产品代码NGX

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

BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set is the device name listed in this FDA 510(k) record. The listed applicant is Bemer Int AG. It received FDA 510(k) clearance on 2021-02-04 under 510(k) number K210174. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set?

BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set is a medical device that received FDA 510(k) clearance on 2021-02-04. The listed applicant is Bemer Int AG. The 510(k) number is K210174.

When did BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set receive FDA 510(k) clearance?

BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set received FDA 510(k) clearance on 2021-02-04, under 510(k) number K210174.

Who is the listed applicant for BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set?

The FDA 510(k) record lists Bemer Int AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set?

The FDA product code for BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set is NGX.

列明Bemer Int AG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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