SaviSafe 安全设备
K号: K230287 · 2023-11-21
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决定日期2023-11-21
产品代码MEG
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
SaviSafe Safety Device is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Savicred Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K230287. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SaviSafe Safety Device?
SaviSafe Safety Device is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Suzhou Savicred Biotechnology Co., Ltd.. The 510(k) number is K230287.
When did SaviSafe Safety Device receive FDA 510(k) clearance?
SaviSafe Safety Device received FDA 510(k) clearance on 2023-11-21, under 510(k) number K230287.
Who is the listed applicant for SaviSafe Safety Device?
The FDA 510(k) record lists Suzhou Savicred Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SaviSafe Safety Device?
The FDA product code for SaviSafe Safety Device is MEG.
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：MEG）
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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