Matreneu经皮球囊压迫套件
K号: K220920 · 2022-09-07
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决定日期2022-09-07
产品代码HAO
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Matreneu Percutaneous Balloon Compression Kit is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Shineyard Medical Device Co. , Ltd.. It received FDA 510(k) clearance on 2022-09-07 under 510(k) number K220920. The device is classified under product code HAO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Matreneu Percutaneous Balloon Compression Kit?
Matreneu Percutaneous Balloon Compression Kit is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is Shenzhen Shineyard Medical Device Co. , Ltd.. The 510(k) number is K220920.
When did Matreneu Percutaneous Balloon Compression Kit receive FDA 510(k) clearance?
Matreneu Percutaneous Balloon Compression Kit received FDA 510(k) clearance on 2022-09-07, under 510(k) number K220920.
Who is the listed applicant for Matreneu Percutaneous Balloon Compression Kit?
The FDA 510(k) record lists Shenzhen Shineyard Medical Device Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Matreneu Percutaneous Balloon Compression Kit?
The FDA product code for Matreneu Percutaneous Balloon Compression Kit is HAO.
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