SmartByte 设备
K号: K171165 · 2017-05-18
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决定日期2017-05-18
产品代码ONY
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
SmartByte Device is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Intake. It received FDA 510(k) clearance on 2017-05-18 under 510(k) number K171165. The device is classified under product code ONY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SmartByte Device?
SmartByte Device is a medical device that received FDA 510(k) clearance on 2017-05-18. The listed applicant is Scientific Intake. The 510(k) number is K171165.
When did SmartByte Device receive FDA 510(k) clearance?
SmartByte Device received FDA 510(k) clearance on 2017-05-18, under 510(k) number K171165.
Who is the listed applicant for SmartByte Device?
The FDA 510(k) record lists Scientific Intake as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartByte Device?
The FDA product code for SmartByte Device is ONY.
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官方来源
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