STAR 65
K号: K172147 · 2018-05-25
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决定日期2018-05-25
产品代码MWI
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
---
请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同
器械摘要
STAR 65 is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Pvt, Ltd.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K172147. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the STAR 65?
STAR 65 is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Skanray Technologies Pvt, Ltd.. The 510(k) number is K172147.
When did STAR 65 receive FDA 510(k) clearance?
STAR 65 received FDA 510(k) clearance on 2018-05-25, under 510(k) number K172147.
Who is the listed applicant for STAR 65?
The FDA 510(k) record lists Skanray Technologies Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for STAR 65?
The FDA product code for STAR 65 is MWI.
相关器械（代码：MWI）
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官方来源
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