FDA 510(k)

防护帽

K号: K232528 · 2024-04-30

决定日期2024-04-30

产品代码NHA

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Protective Cap is the device name listed in this FDA 510(k) record. The listed applicant is Neobiotech Co., Ltd.. It received FDA 510(k) clearance on 2024-04-30 under 510(k) number K232528. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Protective Cap?

Protective Cap is a medical device that received FDA 510(k) clearance on 2024-04-30. The listed applicant is Neobiotech Co., Ltd.. The 510(k) number is K232528.

When did Protective Cap receive FDA 510(k) clearance?

Protective Cap received FDA 510(k) clearance on 2024-04-30, under 510(k) number K232528.

Who is the listed applicant for Protective Cap?

The FDA 510(k) record lists Neobiotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Protective Cap?

The FDA product code for Protective Cap is NHA.

列明Neobiotech Co., Ltd.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。

K232049IS-III 活性短植入物 K210903IS 多单元基台系统 K190849IS-III 活性系统_S-窄型 K181137IT-III主动系统 K181138IS-III 活性系统 K181178S-mini 活动夹具

查看所有 9 个设备 →

相关器械（代码：NHA）

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。

K262207水泥固定基台Unidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC K253999通用底座 ASC 启动；通用底座 ASC 非启动；通用底座 MUA ASC；临时基台启动和非启动；愈合基台锥形连接；Omnigrip 临床螺丝钛；Omnigrip 假体螺丝Nobel Biocare AB K261147Neodent植入系统 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。