Stellar LEAP
K号: K163432 · 2017-06-27
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决定日期2017-06-27
产品代码IOR
咨询委员会PM
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决定实质等同
器械摘要
Stellar LEAP is the device name listed in this FDA 510(k) record. The listed applicant is Pdg Product Design Group, Inc.. It received FDA 510(k) clearance on 2017-06-27 under 510(k) number K163432. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Stellar LEAP?
Stellar LEAP is a medical device that received FDA 510(k) clearance on 2017-06-27. The listed applicant is Pdg Product Design Group, Inc.. The 510(k) number is K163432.
When did Stellar LEAP receive FDA 510(k) clearance?
Stellar LEAP received FDA 510(k) clearance on 2017-06-27, under 510(k) number K163432.
Who is the listed applicant for Stellar LEAP?
The FDA 510(k) record lists Pdg Product Design Group, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stellar LEAP?
The FDA product code for Stellar LEAP is IOR.
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相关器械（代码：IOR）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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