FDA 510(k)

SALUS - 卫生器械再处理容器

K号: K172292 · 2017-11-24

决定日期2017-11-24

产品代码KCT

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

SALUS - Hygiene Instrument Reprocessing Container is the device name listed in this FDA 510(k) record. The listed applicant is Scican , Ltd.. It received FDA 510(k) clearance on 2017-11-24 under 510(k) number K172292. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SALUS - Hygiene Instrument Reprocessing Container?

SALUS - Hygiene Instrument Reprocessing Container is a medical device that received FDA 510(k) clearance on 2017-11-24. The listed applicant is Scican , Ltd.. The 510(k) number is K172292.

When did SALUS - Hygiene Instrument Reprocessing Container receive FDA 510(k) clearance?

SALUS - Hygiene Instrument Reprocessing Container received FDA 510(k) clearance on 2017-11-24, under 510(k) number K172292.

Who is the listed applicant for SALUS - Hygiene Instrument Reprocessing Container?

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

What is the FDA product code for SALUS - Hygiene Instrument Reprocessing Container?

The FDA product code for SALUS - Hygiene Instrument Reprocessing Container is KCT.

列明Scican , 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。

K214057STATIM 6000B Vacuum Autoclave K210326Bravo G4腔室高压灭菌器 K192910STATClave G4 Chamber Autoclave K190062STATCLAVE G4 Chamber Autoclave

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。