DripAssist Plus
K号: K172242 · 2018-05-25
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决定日期2018-05-25
产品代码FLN
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
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器械摘要
DripAssist Plus is the device name listed in this FDA 510(k) record. The listed applicant is Shift Labs, Inc.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K172242. The device is classified under product code FLN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DripAssist Plus?
DripAssist Plus is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Shift Labs, Inc.. The 510(k) number is K172242.
When did DripAssist Plus receive FDA 510(k) clearance?
DripAssist Plus received FDA 510(k) clearance on 2018-05-25, under 510(k) number K172242.
Who is the listed applicant for DripAssist Plus?
The FDA 510(k) record lists Shift Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DripAssist Plus?
The FDA product code for DripAssist Plus is FLN.
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官方来源
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