赛利斯牙科2.0
K号: K193369 · 2020-04-14
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器械摘要
Xelis Dental 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Infinitt Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2020-04-14 under 510(k) number K193369. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Xelis Dental 2.0?
Xelis Dental 2.0 is a medical device that received FDA 510(k) clearance on 2020-04-14. The listed applicant is Infinitt Healthcare Co., Ltd.. The 510(k) number is K193369.
When did Xelis Dental 2.0 receive FDA 510(k) clearance?
Xelis Dental 2.0 received FDA 510(k) clearance on 2020-04-14, under 510(k) number K193369.
Who is the listed applicant for Xelis Dental 2.0?
The FDA 510(k) record lists Infinitt Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Xelis Dental 2.0?
The FDA product code for Xelis Dental 2.0 is LLZ.
相关临床试验
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列明Infinitt Healthcare Co., Ltd.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：LLZ）
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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请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。Taiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC
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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