eUnity
K号: K161515 · 2016-11-15
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器械摘要
eUnity is the device name listed in this FDA 510(k) record. The listed applicant is Client Outlook, Inc.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K161515. 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 eUnity?
eUnity is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Client Outlook, Inc.. The 510(k) number is K161515.
When did eUnity receive FDA 510(k) clearance?
eUnity received FDA 510(k) clearance on 2016-11-15, under 510(k) number K161515.
Who is the listed applicant for eUnity?
The FDA 510(k) record lists Client Outlook, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for eUnity?
The FDA product code for eUnity is LLZ.
相关临床试验
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列明Client Outlook, Inc.为申报人的其他记录
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相关器械（代码：LLZ）
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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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