FDA 510(k)

STERRAD® NX 消毒器，配备 ALLClear® 技术

K号: K160818 · 2016-09-27

决定日期2016-09-27

产品代码MLR

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

STERRAD® NX Sterilizer with ALLClear™ Technology is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K160818. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the STERRAD® NX Sterilizer with ALLClear™ Technology?

STERRAD® NX Sterilizer with ALLClear™ Technology is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Advanced Sterilization Products. The 510(k) number is K160818.

When did STERRAD® NX Sterilizer with ALLClear™ Technology receive FDA 510(k) clearance?

STERRAD® NX Sterilizer with ALLClear™ Technology received FDA 510(k) clearance on 2016-09-27, under 510(k) number K160818.

Who is the listed applicant for STERRAD® NX Sterilizer with ALLClear™ Technology?

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

What is the FDA product code for STERRAD® NX Sterilizer with ALLClear™ Technology?

The FDA product code for STERRAD® NX Sterilizer with ALLClear™ Technology is MLR.

列明Advanced Sterilization Products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。

K234082STERRAD® 100NX 消毒器，配备 ALLClear® 技术和 ULTRA GI® 循环（10104）；APTIMAX® 仪器托盘，用于 ULTRA GI® 循环（011077）K163598泰维克自封袋带STERRAD化学指示剂，泰维克卷材带STERRAD化学指示剂，泰维克热封袋带STERRAD化学指示剂 K162007STERRAD NX 消毒器 K160903STERRAD 100NX 消毒器，配备 ALLClearTM 技术 K151725STERRAD NX 消毒器，STERRAD 100NX 消毒器

相关器械（代码：MLR）

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。

K252843STERRAD 100NX 消毒系统，配备 ALLClear 技术（10104）Advanced Sterilization Products, Inc.K250802STERRAD® 100NX 消毒器，配备 ALLClear® 技术（10104）Advanced Sterilization Products, Inc.K231893LOWTEM Crystal 120Lowtem Co., Ltd.K234082STERRAD® 100NX 消毒器，配备 ALLClear® 技术和 ULTRA GI® 循环（10104）；APTIMAX® 仪器托盘，用于 ULTRA GI® 循环（011077）Advanced Sterilization Products K233762SteroScope® 灭菌技术系统Ideate Medical, Inc.K233065V-PRO maX 2 低温灭菌系统Steris

官方来源

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