Macroduct 先进型 3710 模型
K号: K180627 · 2018-07-27
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决定日期2018-07-27
产品代码KTB
咨询委员会PM
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决定实质等同
器械摘要
Macroduct Advanced Model 3710 is the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup, Inc.. It received FDA 510(k) clearance on 2018-07-27 under 510(k) number K180627. The device is classified under product code KTB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Macroduct Advanced Model 3710?
Macroduct Advanced Model 3710 is a medical device that received FDA 510(k) clearance on 2018-07-27. The listed applicant is Elitechgroup, Inc.. The 510(k) number is K180627.
When did Macroduct Advanced Model 3710 receive FDA 510(k) clearance?
Macroduct Advanced Model 3710 received FDA 510(k) clearance on 2018-07-27, under 510(k) number K180627.
Who is the listed applicant for Macroduct Advanced Model 3710?
The FDA 510(k) record lists Elitechgroup, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Macroduct Advanced Model 3710?
The FDA product code for Macroduct Advanced Model 3710 is KTB.
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