FDA 510(k)

V24 自含式生物指示剂，V24 生物指示剂挑战包

K号: K172748 · 2018-02-09

决定日期2018-02-09

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

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K172748. 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 VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Steris Corporations. The 510(k) number is K172748.

When did VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack receive FDA 510(k) clearance?

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack received FDA 510(k) clearance on 2018-02-09, under 510(k) number K172748.

Who is the listed applicant for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

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

What is the FDA product code for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

The FDA product code for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is FRC.

列明Steris Corporations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。

K203630BioGuard 空气/水吸阀 K190104SYSTEM 1E 液体化学灭菌剂处理系统，SYSTEM 1 内窥镜液体化学灭菌剂处理系统 K183295Celerity HP 化学指示剂（CI）K183300V24 自含式生物指示剂，V24 生物指示剂挑战包 K182931验证一体式蒸汽可重复使用测试包，验证一体式蒸汽可重复使用测试包带步数计数器，验证一体式蒸汽可重复使用测试包带追踪标签 K180342SYSTEM 1E 液体化学灭菌剂处理系统

查看所有 7 个设备 →

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 K250061Celerity 孵化箱STERIS Corporation 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

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。