FDA 510(k)

STERRAD VELOCITY 生物指示剂/过程挑战装置和阅读器

K号: K192025 · 2020-01-23

申请人Advanced Sterilization Products (Asp)

决定日期2020-01-23

产品代码FRC

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 VELOCITY Biological Indicator/Process Challenge Device and Reader is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K192025. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Advanced Sterilization Products (Asp). The 510(k) number is K192025.

When did STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader receive FDA 510(k) clearance?

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader received FDA 510(k) clearance on 2020-01-23, under 510(k) number K192025.

Who is the listed applicant for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

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

What is the FDA product code for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

The FDA product code for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is FRC.

列明Advanced Sterilization Products (Asp)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。

K181472AEROFLEX™ Զ˿ AUTOSURE™ MRC ʾ K182404STERRAD VELOCITY 生物指示剂 K170039STERRAD VELOCITY 生物指示剂和阅读器 K152189EVOTECH ECR

相关器械（代码：FRC）

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。

K260766Celerity 5 HP 生物指示剂（LCB052）STERIS Corporation K252680Celerity™ 20 HP 生物指示剂STERIS Corporation K251122Terragene® Bionova® BT20 生物指示器Terragene K251452Celerity 5 HP 生物指示剂（LCB052）；Celerity 5 HP 挑战包（LCB059）；Celerity 20 HP 生物指示剂（LCB044）；Celerity 20 HP 挑战包（LCB045）Steris K250044Celerity 5 HP 生物指示剂（LCB052）；Celerity 5 HP 挑战包（LCB059）；Celerity 20 HP 生物指示剂（LCB044）；Celerity 20 HP 挑战包（LCB045）STERIS Corporation K250061Celerity 孵化箱STERIS Corporation

官方来源

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