FDA 510(k)

DropSafeTM SicuraTM

K号: K223353 · 2022-12-02

决定日期2022-12-02

产品代码FMI

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

DropSafeTM SicuraTM is the device name listed in this FDA 510(k) record. The listed applicant is Pikdare Spa. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K223353. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DropSafeTM SicuraTM?

DropSafeTM SicuraTM is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Pikdare Spa. The 510(k) number is K223353.

When did DropSafeTM SicuraTM receive FDA 510(k) clearance?

DropSafeTM SicuraTM received FDA 510(k) clearance on 2022-12-02, under 510(k) number K223353.

Who is the listed applicant for DropSafeTM SicuraTM?

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

What is the FDA product code for DropSafeTM SicuraTM?

The FDA product code for DropSafeTM SicuraTM is FMI.

列明Pikdare Spa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。

K203792Insupen Pen 针，Insupen ORIGINAl Pen 针，Insupen ADVANCED 针

相关器械（代码：FMI）

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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