Diacare 7000
K号: K211207 · 2022-06-06
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决定日期2022-06-06
产品代码PBX
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
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器械摘要
Diacare 7000 is the device name listed in this FDA 510(k) record. The listed applicant is Globus Sport and Health Technologies, LLC. It received FDA 510(k) clearance on 2022-06-06 under 510(k) number K211207. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Diacare 7000?
Diacare 7000 is a medical device that received FDA 510(k) clearance on 2022-06-06. The listed applicant is Globus Sport and Health Technologies, LLC. The 510(k) number is K211207.
When did Diacare 7000 receive FDA 510(k) clearance?
Diacare 7000 received FDA 510(k) clearance on 2022-06-06, under 510(k) number K211207.
Who is the listed applicant for Diacare 7000?
The FDA 510(k) record lists Globus Sport and Health Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Diacare 7000?
The FDA product code for Diacare 7000 is PBX.
相关临床试验
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相关器械（代码：PBX）
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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