FDA 510(k)

STERRAD 100NX 消毒器，配备 ALLClearTM 技术

K号: K160903 · 2016-09-26

决定日期2016-09-26

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 100NX Sterilizer with ALLClearTM 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 2016-09-26 under 510(k) number K160903. 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 100NX Sterilizer with ALLClearTM Technology?

STERRAD 100NX Sterilizer with ALLClearTM Technology is a medical device that received FDA 510(k) clearance on 2016-09-26. The listed applicant is Advanced Sterilization Products. The 510(k) number is K160903.

When did STERRAD 100NX Sterilizer with ALLClearTM Technology receive FDA 510(k) clearance?

STERRAD 100NX Sterilizer with ALLClearTM Technology received FDA 510(k) clearance on 2016-09-26, under 510(k) number K160903.

Who is the listed applicant for STERRAD 100NX Sterilizer with ALLClearTM 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 100NX Sterilizer with ALLClearTM Technology?

The FDA product code for STERRAD 100NX Sterilizer with ALLClearTM 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 K160818STERRAD® NX 消毒器，配备 ALLClear® 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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