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FDA 510(k)

ThermaCor 1200 一次性套装，用于ThermaCor 1200 快速热灌注系统

K号: K202461 · 2022-08-12

申请人Smisson-Cartledge Biomedical, LLC
决定日期2022-08-12
产品代码LGZ
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Smisson-Cartledge Biomedical, LLC. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K202461. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System?

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Smisson-Cartledge Biomedical, LLC. The 510(k) number is K202461.

When did ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System receive FDA 510(k) clearance?

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System received FDA 510(k) clearance on 2022-08-12, under 510(k) number K202461.

Who is the listed applicant for ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System?

The FDA 510(k) record lists Smisson-Cartledge Biomedical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System?

The FDA product code for ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System is LGZ.

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。

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相关器械（代码：LGZ）

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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