BEACON Caresystem Model 00002144
K号: K192584 · 2019-12-18
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决定日期2019-12-18
产品代码BZK
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
BEACON Caresystem Model 00002144 is the device name listed in this FDA 510(k) record. The listed applicant is Mermaid Care A/S. It received FDA 510(k) clearance on 2019-12-18 under 510(k) number K192584. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BEACON Caresystem Model 00002144?
BEACON Caresystem Model 00002144 is a medical device that received FDA 510(k) clearance on 2019-12-18. The listed applicant is Mermaid Care A/S. The 510(k) number is K192584.
When did BEACON Caresystem Model 00002144 receive FDA 510(k) clearance?
BEACON Caresystem Model 00002144 received FDA 510(k) clearance on 2019-12-18, under 510(k) number K192584.
Who is the listed applicant for BEACON Caresystem Model 00002144?
The FDA 510(k) record lists Mermaid Care A/S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BEACON Caresystem Model 00002144?
The FDA product code for BEACON Caresystem Model 00002144 is BZK.
相关临床试验
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相关器械（代码：BZK）
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。
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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