OPTI® B-Lac 卡片
K号: K200986 · 2021-08-02
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决定日期2021-08-02
产品代码CHL
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
OPTI® B-Lac Cassette is the device name listed in this FDA 510(k) record. The listed applicant is Opti Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-08-02 under 510(k) number K200986. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OPTI® B-Lac Cassette?
OPTI® B-Lac Cassette is a medical device that received FDA 510(k) clearance on 2021-08-02. The listed applicant is Opti Medical Systems, Inc.. The 510(k) number is K200986.
When did OPTI® B-Lac Cassette receive FDA 510(k) clearance?
OPTI® B-Lac Cassette received FDA 510(k) clearance on 2021-08-02, under 510(k) number K200986.
Who is the listed applicant for OPTI® B-Lac Cassette?
The FDA 510(k) record lists Opti Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OPTI® B-Lac Cassette?
The FDA product code for OPTI® B-Lac Cassette is CHL.
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。
相关器械（代码：CHL）
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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