aPROMISE X
K号: K220590 · 2022-04-29
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器械摘要
aPROMISE X is the device name listed in this FDA 510(k) record. The listed applicant is Exini Diagnostics AB. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K220590. 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 aPROMISE X?
aPROMISE X is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Exini Diagnostics AB. The 510(k) number is K220590.
When did aPROMISE X receive FDA 510(k) clearance?
aPROMISE X received FDA 510(k) clearance on 2022-04-29, under 510(k) number K220590.
Who is the listed applicant for aPROMISE X?
The FDA 510(k) record lists Exini Diagnostics AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for aPROMISE X?
The FDA product code for aPROMISE X is LLZ.
相关临床试验
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列明Exini Diagnostics AB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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