FDA 510(k)

STERRAD 100NX 消毒器，配备 ALLClear 技术

K号: K212174 · 2021-10-09

申请人Advanced Sterilization Products, Inc.

决定日期2021-10-09

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 ALLClear Technology is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products, Inc.. It received FDA 510(k) clearance on 2021-10-09 under 510(k) number K212174. 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 ALLClear Technology?

STERRAD 100NX Sterilizer with ALLClear Technology is a medical device that received FDA 510(k) clearance on 2021-10-09. The listed applicant is Advanced Sterilization Products, Inc.. The 510(k) number is K212174.

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

STERRAD 100NX Sterilizer with ALLClear Technology received FDA 510(k) clearance on 2021-10-09, under 510(k) number K212174.

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

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

What is the FDA product code for STERRAD 100NX Sterilizer with ALLClear Technology?

The FDA product code for STERRAD 100NX Sterilizer with ALLClear Technology is MLR.

列明Advanced Sterilization Products, Inc.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。

K252843STERRAD 100NX 消毒系统，配备 ALLClear 技术（10104）K250802STERRAD® 100NX 消毒器，配备 ALLClear® 技术（10104）K234084STERRAD® 化学指示剂（CI）条带（14100）；STERRAD® SEALSURE® 化学指示剂（CI）胶带（14202NL）；STERRAD VELOCITY® 生物指示剂（BI）（43210）（60个）；STERRAD VELOCITY® 生物指示剂（BI）（43210-30）（30个）；STERRAD VELOCITY® 阅读器（43220）；ULTRA GI® 过程挑战装置（PCD）（43400）（30个）K220404STERRAD NX 配备 ALLClear 技术

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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