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FDA 510(k)

Doctor Tecar Plus, Doctor Tecar Smart

K号: K221043 · 2023-02-17

决定日期2023-02-17
产品代码PBX
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Doctor Tecar Plus, Doctor Tecar Smart is the device name listed in this FDA 510(k) record. The listed applicant is Mectronic Medicale S.R.L.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K221043. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Doctor Tecar Plus, Doctor Tecar Smart?

Doctor Tecar Plus, Doctor Tecar Smart is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Mectronic Medicale S.R.L.. The 510(k) number is K221043.

When did Doctor Tecar Plus, Doctor Tecar Smart receive FDA 510(k) clearance?

Doctor Tecar Plus, Doctor Tecar Smart received FDA 510(k) clearance on 2023-02-17, under 510(k) number K221043.

Who is the listed applicant for Doctor Tecar Plus, Doctor Tecar Smart?

The FDA 510(k) record lists Mectronic Medicale S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Doctor Tecar Plus, Doctor Tecar Smart?

The FDA product code for Doctor Tecar Plus, Doctor Tecar Smart is PBX.

相关临床试验

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。

列明Mectronic Medicale S.R.L.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。

相关器械(代码:PBX)

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。

官方来源

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