FDA 510(k)

CELERITY HP 化学指示剂

K号: K213262 · 2022-01-07

决定日期2022-01-07

产品代码QKM

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

CELERITY HP Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K213262. The device is classified under product code QKM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CELERITY HP Chemical Indicator?

CELERITY HP Chemical Indicator is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is STERIS Corporation. The 510(k) number is K213262.

When did CELERITY HP Chemical Indicator receive FDA 510(k) clearance?

CELERITY HP Chemical Indicator received FDA 510(k) clearance on 2022-01-07, under 510(k) number K213262.

Who is the listed applicant for CELERITY HP Chemical Indicator?

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

What is the FDA product code for CELERITY HP Chemical Indicator?

The FDA product code for CELERITY HP Chemical Indicator is QKM.

列明STERIS Corporation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。

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官方来源

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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。