aPROMISE
K号: K211655 · 2021-07-27
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器械摘要
aPROMISE 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 2021-07-27 under 510(k) number K211655. 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?
aPROMISE is a medical device that received FDA 510(k) clearance on 2021-07-27. The listed applicant is Exini Diagnostics AB. The 510(k) number is K211655.
When did aPROMISE receive FDA 510(k) clearance?
aPROMISE received FDA 510(k) clearance on 2021-07-27, under 510(k) number K211655.
Who is the listed applicant for aPROMISE?
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?
The FDA product code for aPROMISE 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
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