EOGas 4 内窥镜-灭菌测试 RRBI
K号: K202879 · 2021-03-03
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决定日期2021-03-03
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
EOGas 4 Endo-SteriTest RRBI is the device name listed in this FDA 510(k) record. The listed applicant is Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2021-03-03 under 510(k) number K202879. 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 EOGas 4 Endo-SteriTest RRBI?
EOGas 4 Endo-SteriTest RRBI is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Andersen Sterilizers, Inc.. The 510(k) number is K202879.
When did EOGas 4 Endo-SteriTest RRBI receive FDA 510(k) clearance?
EOGas 4 Endo-SteriTest RRBI received FDA 510(k) clearance on 2021-03-03, under 510(k) number K202879.
Who is the listed applicant for EOGas 4 Endo-SteriTest RRBI?
The FDA 510(k) record lists Andersen Sterilizers, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EOGas 4 Endo-SteriTest RRBI?
The FDA product code for EOGas 4 Endo-SteriTest RRBI 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Andersen Sterilizers, 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。
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。
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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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