自含生物指示器
K号: K200970 · 2020-12-28
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决定日期2020-12-28
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
Self-Contained Biological Indicator is the device name listed in this FDA 510(k) record. The listed applicant is True Indicating, LLC. It received FDA 510(k) clearance on 2020-12-28 under 510(k) number K200970. 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 Self-Contained Biological Indicator?
Self-Contained Biological Indicator is a medical device that received FDA 510(k) clearance on 2020-12-28. The listed applicant is True Indicating, LLC. The 510(k) number is K200970.
When did Self-Contained Biological Indicator receive FDA 510(k) clearance?
Self-Contained Biological Indicator received FDA 510(k) clearance on 2020-12-28, under 510(k) number K200970.
Who is the listed applicant for Self-Contained Biological Indicator?
The FDA 510(k) record lists True Indicating, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Self-Contained Biological Indicator?
The FDA product code for Self-Contained Biological Indicator is FRC.
相关临床试验
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。
列明True Indicating, LLC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。
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 CorporationK252680Celerity™ 20 HP 生物指示剂STERIS CorporationK251122Terragene® Bionova® BT20 生物指示器TerrageneK251452Celerity 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）SterisK250061Celerity 孵化箱STERIS CorporationK250044Celerity 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。
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